Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following device
Summary
The FDA issued a Class II for Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software App by Medtronic Neuromodulation. Reason: Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged .
Details
Source
Device Recall
External ID
Z-2201-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
Product Description
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
Lot/Code Info: Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900A, GTIN 00643169890923, Serial Numbers: NPL0004445; 2. Model Number CT900B, GTIN 00643169890947, Serial Numbers: NPL1000042, NPL1000045, NPL1000046, NPL1000048, NPL1000050, NPL1000051, NPL1000053, NPL1000054, NPL1000059, NPL1000060, NPL1000062, NPL1000065, NPL1000069, NPL1000070, NPL1000071, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000077, NPL1000081, NPL1000082, NPL1000083, NPL1000085, NPL1000086, NPL1000087, NPL1000090, NPL1000091, NPL1000093, NPL1000094, NPL1000098, NPL1000117, NPL1000133, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000159, NPL1000160, NPL1000164, NPL1000166, NPL1000167, NPL1000169, NPL1000173, NPL1000174, NPL1000179, NPL1000180, NPL1000183, NPL1000185, NPL1000186, NPL1000187, NPL1000188, NPL1000191, NPL1000192, NPL1000193, NPL1000194, NPL1000195, NPL1000196, NPL1000230, NPL1000235, NPL1000237, NPL1000242, NPL1000244, NPL1000245, NPL1000246, NPL1000248, NPL1000249, NPL1000252, NPL1000254, NPL1000257, NPL1000258, NPL1000281, NPL1000292, NPL1000297, NPL1000301, NPL1000303, NPL1000307, NPL1000321, NPL1000322, NPL1000323, NPL1000325, NPL1000326, NPL1000332, NPL1000334, NPL1000343, NPL1000361, NPL1000362, NPL1000363, NPL1000364, NPL1000365, NPL1000366, NPL1000367, NPL1000369, NPL1000370, NPL1000381, NPL1000483, NPL1000486, NPL1000487, NPL1000501, NPL1000502, NPL1000505, NPL1000506, NPL1000507, NPL1000509, NPL1000510, NPL1000512, NPL1000515, NPL1000516, NPL1000518, NPL1000519, NPL1000528, NPL1000529, NPL1000539, NPL1000540, NPL1000555, NPL1000556, NPL1000558, NPL1000560, NPL1000561, NPL1000562, NPL1000563, NPL1000564, NPL1000571, NPL1000573, NPL1000574, NPL1000575, NPL1000576, NPL1000577, NPL1000578, NPL1000580, NPL1000585, NPL1000592, NPL1000603, NPL1000606, NPL1000612, NPL1000627, NPL1000630, NPL1000631, NPL1000632, NPL1000634, NPL1000637, NPL1000641, NPL1000652, NPL1000653, NPL1001194, NPL1001195, NPL1001201, NPL1001204, NPL1001205, NPL1001206, NPL1001207, NPL1001208, NPL1001210, NPL1001211, NPL1001212, NPL1001216, NPL1001223, NPL1001224, NPL1001225, NPL1001226, NPL1001228, NPL1001229, NPL1001230, NPL1001231, NPL1001235, NPL1001236, NPL1001237, NPL1001238, NPL1001240, NPL1001241, NPL1001243, NPL1001244, NPL1001250, NPL1001251, NPL1001254, NPL1001259, NPL1001264, NPL1001265, NPL1001272, NPL1001273, NPL1001274, NPL1001277, NPL1001282, NPL1001283, NPL1001290, NPL1001291, NPL1001306, NPL1001307, NPL1001313, NPL1001314, NPL1001328, NPL1001330, NPL1001332, NPL1001333, NPL1001334, NPL1001336, NPL1001337, NPL1001339, NPL1001341, NPL1001345, NPL1001349, NPL1001350, NPL1001351, NPL1001353, NPL1001354, NPL1001360, NPL1001361, NPL1001362, NPL1001366, NPL1001367, NPL1001369, NPL1001372, NPL1001375, NPL1001380, NPL1001381, NPL1001385, NPL1001386, NPL1001389, NPL1001398, NPL1001407, NPL1001408, NPL1001410, NPL1001412, NPL1001419, NPL1001421, NPL1001423, NPL1001430, NPL1001431, NPL1001434, NPL1001435, NPL1001436, NPL1001439, NPL1001445, NPL1001449, NPL1001458, NPL1001461, NPL1001464, NPL1001465, NPL1001468, NPL1001482, NPL1001483, NPL1001486, NPL1001499, NPL1001500, NPL1001505, NPL1001507, NPL1001510, NPL1001512, NPL1001513, NPL1001514, NPL1001518, NPL1001520, NPL1001524, NPL1001526, NPL1001531, NPL1001532, NPL1001537, NPL1001539, NPL1001540, NPL1001541, NPL1001542, NPL1001544, NPL1001545, NPL1001546, NPL1001547, NPL1001549, NPL1001550, NPL1001678, NPL1001689, NPL1001694, NPL1001695, NPL1001697, NPL1001699, NPL1001700, NPL1001701, NPL1001702, NPL1001705, NPL1001707, NPL1001708, NPL1001709, NPL1001710, NPL1001711, NPL1001716, NPL1001717, NPL1001723, NPL1001724, NPL1001727, NPL1001728, NPL1001739, NPL1001740, NPL1001741, NPL1001742, NPL1001743, NPL1001744, NPL1001745, NPL1001748, NPL1001749, NPL1001750, NPL1001754, NPL1001755, NPL1001756, NPL1001757, NPL1001759, NPL1001760, NPL1001761, NPL1001763, NPL1001764, NPL1001765, NPL1001766, NPL1001767, NPL1001769, NPL1001770, NPL1001773, NPL1001777, NPL1001784, NPL1001787, NPL1001789, NPL1001792, NPL1001794, NPL1001795, NPL1001797, NPL1001798, NPL1001799, NPL1001800, NPL1001801, NPL1001803, NPL1001804, NPL1001805, NPL1001806, NPL1001811, NPL1001812, NPL1001815, NPL1001816, NPL1001817, NPL1001820, NPL1001823, NPL1001824, NPL1001825, NPL1001829, NPL1001830, NPL1001833, NPL1001841, NPL1001842, NPL1001843, NPL1001844, NPL1001847, NPL1001875, NPL1001876, NPL1001877, NPL1001879, NPL1001880, NPL1001881, NPL1001882, NPL1001884, NPL1001885, NPL1001886, NPL1001887, NPL1001888, NPL1001889, NPL1001891, NPL1001897, NPL1001899, NPL1001900, NPL1001901, NPL1001903, NPL1001904, NPL1001905, NPL1001937, NPL1001940, NPL1001946, NPL1001947, NPL1001948, NPL1001950, NPL1001955, NPL1001957, NPL1001959, NPL1001963, NPL1001966, NPL1001968, NPL1001969, NPL1001970, NPL1001971, NPL1001972, NPL1001973, NPL1001974, NPL1001975, NPL1001976, NPL1001977, NPL1001995, NPL1001996, NPL1002004, NPL1002007, NPL1002010, NPL1002016, NPL1002020, NPL1002021, NPL1002025, NPL1002034, NPL1002035, NPL1002038, NPL1002048, NPL1002049, NPL1002050, NPL1002051, NPL1002053, NPL1002054, NPL1002064, NPL1002065, NPL1002066, NPL1002067, NPL1002068, NPL1002088, NPL1002089, NPL1002090, NPL1002091, NPL1002092, NPL1002093, NPL1002094, NPL1002095, NPL1002124, NPL1002126, NPL1002132, NPL1002137, NPL1002146, NPL1002152, NPL1002190, NPL1002191, NPL1002192, NPL1002194, NPL1002200, NPL1002203, NPL1002211, NPL1002214, NPL1002219, NPL1002221, NPL1002222, NPL1002223, NPL1002224, NPL1002225, NPL1002226, NPL1002227, NPL1002228, NPL1002229, NPL1002230, NPL1002231, NPL1002232, NPL1002233, NPL1002234, NPL1002236, NPL1002238, NPL1002239, NPL1002240, NPL1002243, NPL1002244, NPL1002245, NPL1002246, NPL1002247, NPL1002254, NPL1002255, NPL1002256, NPL1002311, NPL1002312, NPL1002313, NPL1002316, NPL1002324, NPL1002329, NPL1002330, NPL1002334, NPL1002335, NPL1002337, NPL1002338, NPL1002339, NPL1002340, NPL1002341, NPL1002342, NPL1002343, NPL1002344, NPL1002347, NPL1002349, NPL1002355, NPL1002356, NPL1002357, NPL1002358, NPL1002359, NPL1002360, NPL1002361, NPL1002362, NPL1002363, NPL1002364, NPL1002367, NPL1002368, NPL1002369, NPL1002370, NPL1002371, NPL1002373, NPL1002375, NPL1002380, NPL1002381, NPL1002382, NPL1002383, NPL1002386, NPL1002392, NPL1002396, NPL1002399, NPL1002401, NPL1002405, NPL1002408, NPL1002409, NPL1002410, NPL1002411, NPL1002412, NPL1002413, NPL1002414, NPL1002415, NPL1002416, NPL1002417, NPL1002418, NPL1002421, NPL1002427, NPL1002428, NPL1002431, NPL1002436, NPL1002438, NPL1002443, NPL1002445, NPL1002460, NPL1002461, NPL1002462, NPL1002464, NPL1002465, NPL1002466, NPL1002467, NPL1002470, NPL1002471, NPL1002474, NPL1002482, NPL1002484, NPL1002490, NPL1002491, NPL1002495, NPL1002496, NPL1002499, NPL1002500, NPL1002501, NPL1002502, NPL1002503, NPL1002505, NPL1002508, NPL1002521, NPL1002530, NPL1002537, NPL1002540, NPL1002544, NPL1002545, NPL1002548, NPL1002549, NPL1002555, NPL1002556, NPL1002557, NPL1002564, NPL1002567, NPL1002568, NPL1002572, NPL1002592, NPL1002593, NPL1002594, NPL1002595, NPL1002596, NPL1002613, NPL1002616, NPL1002617, NPL1002618, NPL1002620, NPL1002626, NPL1002628, NPL1002630, NPL1002631, NPL1002632, NPL1002636, NPL1002637, NPL1002638, NPL1002639, NPL1002640, NPL1002642, NPL1002646, NPL1002648, NPL1002650, NPL1002651, NPL1002652, NPL1002653, NPL1002654, NPL1002656, NPL1002659, NPL1002661, NPL1002666, NPL1002668, NPL1002669, NPL1002671, NPL1002673, NPL1002677, NPL1002679, NPL1002684, NPL1002685, NPL1002686, NPL1002687, NPL1002689, NPL1002690, NPL1002693, NPL1002695, NPL1002696, NPL1002698, NPL1002706, NPL1002709, NPL1002710, NPL1002711, NPL1002712, NPL1002714, NPL1002718, NPL1002719, NPL1002720, NPL1002721, NPL1002728, NPL1002729, NPL1002730, NPL1002731, NPL1002732, NPL1002733, NPL1002735, NPL1002736, NPL1002737, NPL1002739, NPL1002740, NPL1002741, NPL1002743, NPL1002753, NPL1002756, NPL1002757, NPL1002760, NPL1002761, NPL1002778, NPL1002779, NPL1002780, NPL1002781, NPL1002784, NPL1002786, NPL1002787, NPL1002789, NPL1002791, NPL1002792, NPL1002794, NPL1002796, NPL1002800; 3. Model Number CT900C, GTIN 00643169890961, Serial Numbers: NPL1000429, NPL1000430, NPL1000442, NPL1000443, NPL1000444, NPL1000445, NPL1000446, NPL1000447, NPL1000448, NPL1000451, NPL1000453, NPL1000771, NPL1000774, NPL1000776, NPL1000777, NPL1000780, NPL1000781, NPL1000794, NPL1000795, NPL1000797, NPL1000798, NPL1000799, NPL1000802, NPL1000804, NPL1000805, NPL1000806, NPL1000808, NPL1000809, NPL1000810, NPL1000811, NPL1000813, NPL1000814, NPL1000815, NPL1000817, NPL1000818, NPL1000819, NPL1000827, NPL1000830, NPL1000832, NPL1000833, NPL1000834, NPL1000835, NPL1000838, NPL1000845, NPL1000847, NPL1000854, NPL1000855, NPL1000858, NPL1001552, NPL1001562, NPL1001564, NPL1001565, NPL1001566, NPL1001570, NPL1001571, NPL1001574, NPL1001582, NPL1001583, NPL1001588, NPL1001590, NPL1001591, NPL1001592, NPL1001594, NPL1001595, NPL1001596, NPL1001601, NPL1001602, NPL1001605, NPL1001606, NPL1001607, NPL1001608, NPL1001609, NPL1001610, NPL1001611, NPL1001615, NPL1001617, NPL1001618, NPL1001620, NPL1001621, NPL1001627, NPL1001629, NPL1001630, NPL1001631, NPL1001632, NPL1001637, NPL1001638, NPL1001644, NPL1001645, NPL1001647, NPL1001649, NPL1001650, NPL1001651, NPL1001652, NPL1001656, NPL1001657, NPL1001670, NPL1001673, NPL1001675, NPL1002257, NPL1002259, NPL1002260, NPL1002262, NPL1002264, NPL1002265, NPL1002266, NPL1002267, NPL1002268, NPL1002275, NPL1002279, NPL1002280, NPL1002281, NPL1002282, NPL1002284, NPL1002285, NPL1002286, NPL1002288, NPL1002294, NPL1002295, NPL1002297, NPL1002298, NPL1002306, NPL1002307, NPL1002308, NPL1002309, NPL1002310; 4. Model Number CT900D, (1) GTIN 00763000077730, Serial Numbers: NPL3000277, NPL3000278, NPL3000279, NPL3000280, NPL3000281, NPL3000282, NPL3000283, NPL3000285, NPL3000290, NPL3000292, NPL3000293, NPL3000298, NPL3000299, NPL3000300, NPL3000301, NPL3000304, NPL3000305, NPL3000309, NPL3000310, NPL3000312, NPL3000460, NPL3000555, NPL3000563, NPL3000582, NPL3000590, NPL3000591, NPL3002090, NPL3002102, NPL3002311, NPL3002312, NPL3002313, NPL3002314, NPL3002315, NPL3002316, NPL3002318, NPL3002760, NPL3002761, NPL3002762, NPL3002763, NPL3002816, NPL3002995, NPL3002997, NPL3002998, NPL3002999, NPL3003000, NPL3003001, NPL3003002, NPL3003003, NPL3003004, NPL3003005, NPL3003009, NPL3003010, NPL3003011, NPL3003012, NPL3003013, NPL3003014, NPL3003015, NPL3003016, NPL3003018, NPL3003021, NPL3003022, NPL3003023, NPL3003024, NPL3003026, NPL3003028, NPL3003029, NPL3003030, NPL3003031, NPL3003032, NPL3003036, NPL3003037, NPL3003038, NPL3003042, NPL3003046, NPL3003048, NPL3003050, NPL3003051, NPL3003054, NPL3003059, NPL3003060, NPL3003062, NPL3003065, NPL3003067, NPL3003068, NPL3003070, NPL3003072, NPL3003073, NPL3003074, NPL3003076, NPL3003077, NPL3003078, NPL3003086, NPL3003260, NPL3003267, NPL3003268, NPL3003271, NPL3003275, NPL3003277, NPL3003280, NPL3003282, NPL3003283, NPL3003284, NPL3003402, NPL3003409, NPL3003412, NPL3003413, NPL3003415, NPL3003416, NPL3003417, NPL3003418, NPL3003419, NPL3003420, NPL3003422, NPL3003423, NPL3003425, NPL3003427, NPL3003513, NPL3003517, NPL3003518, NPL3003521, NPL3003524, NPL3003528, NPL3003529, NPL3003530, NPL3003532, NPL3003533, NPL3003534, NPL3003535, NPL3003536, NPL3003537, NPL3003538, NPL3003539, NPL3003540, NPL3003542, NPL3003543, NPL3003544, NPL3003545, NPL3003546, NPL3003547, NPL3003548, NPL3003549, NPL3003551, NPL3003552, NPL3003558, NPL3003560, NPL3003566, NPL3003567, NPL3003569, NPL3003570, NPL3003576, NPL3003577, NPL3003578, NPL3003579, NPL3003580, NPL3003581, NPL3003598, NPL3003599, NPL3003601, NPL3003745, NPL3003756, NPL3003766, NPL3003817, NPL3003821, NPL3003823, NPL3003824, NPL3003850, NPL3003885, NPL3003886, NPL3003887, NPL3003890, NPL3003891, NPL3003892, NPL3003893, NPL3003894, NPL3003895, NPL3003896, NPL3003897, NPL3003899, NPL3003900, NPL3003901, NPL3003904, NPL3003905, NPL3003906, NPL3003907, NPL3003921, NPL3003923, NPL3003924, NPL3003929, NPL3003943, NPL3003944, NPL3003951, NPL3003952, NPL3003954, NPL3004050, NPL3004052, NPL3004053, NPL3004057, NPL3004061, NPL3004062, NPL3004063, NPL3004064, NPL3004066, NPL3004067, NPL3004068, NPL3004069, NPL3004071, NPL3004072, NPL3004076, NPL3004078, NPL3004081, NPL3004082, NPL3004087, NPL3004095, NPL3004096, NPL3004102, NPL3004114, NPL3004117, NPL3004118, NPL3004139, NPL3004140, NPL3004141, NPL3004143, NPL3004144, NPL3004145, NPL3004146, NPL3004148, NPL3004149, NPL3004151, NPL3004152, NPL3004153, NPL3004340, NPL3004342, NPL3004344, NPL3004345, NPL3004352, NPL3004353, NPL3004417, NPL3004421, NPL3004436, NPL3004793, NPL3004841, NPL3004860, NPL3004871, NPL3004879, NPL3004895, NPL3004897, NPL3004905, NPL3004910, NPL3004913, NPL3004914, NPL3004918, NPL3004925, NPL3004942, NPL3004951, NPL3004952, NPL3004960, NPL3004969, NPL3004971, NPL3004992, NPL3005006, NPL3005009, NPL3005010, NPL3005018, NPL3005025, NPL3005033, NPL3005044, NPL3005053, NPL3005054, NPL3005059, NPL3005060, NPL3005061, NPL3005065, NPL3005075, NPL3005136, NPL3005187, NPL3005199, NPL3005750, NPL3005752, NPL3005760, NPL3005769, NPL3005773, NPL3005779, NPL3005782, NPL3005783, NPL3005785, NPL3005790, NPL3005799, NPL3005801, NPL3005811, NPL3005814, NPL3005817, NPL3005818, NPL3005866, NPL3005876, NPL3005889, NPL3005893, NPL3006002, NPL3006011, NPL3006027, NPL3006033, NPL3006069, NPL3006072, NPL3006084, NPL3006132, NPL3006142, NPL3006146, NPL3006147, NPL3006148, NPL3006151, NPL3006152, NPL3006153, NPL3006155, NPL3006160, NPL3006161, NPL3006167, NPL3006168, NPL3006176, NPL3006179, NPL3006181, NPL3006188, NPL3006189, NPL3006190, NPL3006192, NPL3006194, NPL3006198, NPL3006203, NPL3006205, NPL3006209, NPL3006213, NPL3006217, NPL3006221, NPL3006225, NPL3006230, NPL3006237, NPL3006238, NPL3006242, NPL3006245, NPL3006247, NPL3006248, NPL3006249, NPL3006250, NPL3006253, NPL3006254, NPL3006255, NPL3006267, NPL3006279, NPL3006280, NPL3006289, NPL3006305, NPL3006309, NPL3006310, NPL3006312, NPL3006359, NPL3006360, NPL3006361, NPL3006366, NPL3006372, NPL3006374, NPL3006375, NPL3006377, NPL3006379, NPL3006380, NPL3006381, NPL3006389, NPL3006391, NPL3006392, NPL3006393, NPL3006394, NPL3006399, NPL3006400, NPL3006406, NPL3006407, NPL3006408, NPL3006410, NPL3006413, NPL3006414, NPL3006416, NPL3006417, NPL3006433, NPL3006443, NPL3006445, NPL3006446, NPL3006448, NPL3006449, NPL3006450, NPL3006452, NPL3006453, NPL3006454, NPL3006457, NPL3006458, NPL3006461, NPL3006465, NPL3006468, NPL3006469, NPL3006475, NPL3006476, NPL3006485, NPL3006486, NPL3006487, NPL3006489, NPL3006490, NPL3006491, NPL3006492, NPL3006494, NPL3006495, NPL3006496, NPL3006498, NPL3006513, NPL3006516, NPL3006518, NPL3006519, NPL3006520, NPL3006522, NPL3006523, NPL3006524, NPL3006525, NPL3006526, NPL3006527, NPL3006531, NPL3006532, NPL3006533, NPL3006534, NPL3006536, NPL3006572, NPL3006581, NPL3006586, NPL3006587, NPL3006600, NPL3006601, NPL3006602, NPL3006604, NPL3006605, NPL3006608, NPL3006612, NPL3006620, NPL3006625, NPL3006626, NPL3006627, NPL3006634, NPL3006825, NPL3006827, NPL3006885, NPL3006886, NPL3006887, NPL3006888, NPL3006889, NPL3006900, NPL3006902, NPL3006904, NPL3006909, NPL3006911, NPL3006917, NPL3006918, NPL3006920, NPL3006921, NPL3006922, NPL3006923, NPL3006924, NPL3006930, NPL3006932, NPL3006933, NPL3006934, NPL3006936, NPL3006938, NPL3006944, NPL3006946, NPL3006947, NPL3006948, NPL3006949, NPL3006950, NPL3006951, NPL3006952, NPL3006953, NPL3006954, NPL3006955, NPL3006962, NPL3006963, NPL3006964, NPL3006966, NPL3006967, NPL3006968, NPL3006971, NPL3006972, NPL3006974, NPL3006977, NPL3006979, NPL3006982, NPL3006983, NPL3006985, NPL3006986, NPL3007004, NPL3007011, NPL3007012, NPL3007053, NPL3007268, NPL3007269, NPL3007272, NPL3007273, NPL3007274, NPL3007276, NPL3007277, NPL3007362, NPL3007363, NPL3007365, NPL3007366, NPL3007367, NPL3007368, NPL3007370, NPL3007371, NPL3007372, NPL3007384, NPL3007385, NPL3007393, NPL3007439, NPL3007451, NPL3007453, NPL3007455, NPL3007456, NPL3007457, NPL3007458, NPL3007464, NPL3007465, NPL3007583, NPL3007584, NPL3007585, NPL3007589, NPL3007592, NPL3007593, NPL3007594, NPL3007596, NPL3007601, NPL3007605, NPL3007608, NPL3007611, NPL3007617, NPL3007619, NPL3007621, NPL3007672, NPL3007677, NPL3007679, NPL3007685, NPL3007688, NPL3007776, NPL3007867, NPL3007869, NPL3007873, NPL3007875, NPL3007877, NPL3007878, NPL3007886, NPL3007887, NPL3007889, NPL3007890, NPL3007895, NPL3007900, NPL3007901, NPL3007904, NPL3007907, NPL3007908, NPL3007909, NPL3007910, NPL3007914, NPL3007916, NPL3007917, NPL3007918, NPL3007921, NPL3007924, NPL3007926, NPL3007927, NPL3007929, NPL3007930, NPL3007937, NPL3007947, NPL3007948, NPL3008029, NPL3008031, NPL3008033, NPL3008034, NPL3008036, NPL3008039, NPL3008046, NPL3008048, NPL3008053, NPL3008058, NPL3008068, NPL3010566, NPL3010568, NPL3010569, NPL3010570, NPL3010573, NPL3010578, NPL3010588, NPL3010593, NPL3010607, NPL3010628, NPL3010629, NPL3010631, NPL3010642, NPL3010645, NPL3010647, NPL3010652, NPL3010653, NPL3010658, NPL3010660, NPL3010665, NPL3010683, NPL3010688, NPL3010690, NPL3010691, NPL3010692, NPL3010782, NPL3010784, NPL3010786, NPL3010793, NPL3010800, NPL3010806, NPL3010817, NPL3010820, NPL3010824, NPL3010828, NPL3010829, NPL3010831, NPL3010833, NPL3010835, NPL3010866, NPL3010874, NPL3010876, NPL3010877, NPL3010879, NPL3010880, NPL3010887, NPL3010891, NPL3010892, NPL3010901, NPL3010902, NPL3010904, NPL3010907, NPL3010908, NPL3010910, NPL3010911, NPL3010914, NPL3010915, NPL3010927, NPL3010928, NPL3010934, NPL3010940, NPL3010945, NPL3010946, NPL3010953, NPL3010954, NPL3010955, NPL3010958, NPL3010968, NPL3010991, NPL3010996, NPL3010997, NPL3010998, NPL3011008, NPL3011104, NPL3011106, NPL3011107, NPL3011108, NPL3011109, NPL3011113, NPL3011169, NPL3011217, NPL3011219, NPL3011221, NPL3011224, NPL3011226, NPL3011227, NPL3011228, NPL3011234, NPL3011235, NPL3011236, NPL3011239, NPL3011240, NPL3011241, NPL3011242, NPL3011243, NPL3011244, NPL3011245, NPL3011246, NPL3011247, NPL3011249, NPL3011267, NPL3011269, NPL3011286, NPL3011287, NPL3011367, NPL3011426, NPL3011427, NPL3011428, NPL3011429, NPL3011430, NPL3011434, NPL3011435, NPL3011436, NPL3011437, NPL3011445, NPL3011446, NPL3011447, NPL3011448, NPL3011449, NPL3011452, NPL3011459, NPL3011460, NPL3011462, NPL3011463, NPL3011481, NPL3011482, NPL3011485, NPL3011487, NPL3011489, NPL3011490, NPL3011568, NPL3011569, NPL3011572, NPL3011573, NPL3011574, NPL3011575, NPL3011587, NPL3011589, NPL3011590, NPL3011600, NPL3011602, NPL3011605, NPL3011606, NPL3011607, NPL3011632, NPL3011633, NPL3011637, NPL3011639, NPL3011651, NPL3011652, NPL3011653, NPL3011656, NPL3011701, NPL3011703, NPL3011704, NPL3011705, NPL3011706, NPL3011707, NPL3011708, NPL3011709, NPL3011716, NPL3011718, NPL3011719, NPL3011720, NPL3011725, NPL3011734, NPL3011738, NPL3011739, NPL3011741, NPL3011749, NPL3011750, NPL3011753, NPL3011754, NPL3011756, NPL3011757, NPL3011762, NPL3013178, NPL3013655, NPL3013656, NPL3013665, NPL3013669, NPL3013670, NPL3013671, NPL3013674, NPL3013675, NPL3013676, NPL3013679, NPL3013680, NPL3013683, NPL3013684, NPL3013687, NPL3013699, NPL3013702, NPL3013712, NPL3013713, NPL3013714, NPL3013715, NPL3013717, NPL3013719, NPL3013721, NPL3013740, NPL3013743, NPL3013746, NPL3013748, NPL3013751, NPL3013754, NPL3013755, NPL3013758, NPL3013759, NPL3013760, NPL3013762, NPL3013763, NPL3013764, NPL3013766, NPL3013767, NPL3013768, NPL3013769, NPL3013773, NPL3013781, NPL3013783, NPL3013786, NPL3013795, NPL3013796, NPL3013797, NPL3013798, NPL3013799, NPL3013817, NPL3013818, NPL3013819, NPL3013821, NPL3013825, NPL3013826, NPL3013827, NPL3013830, NPL3013856, NPL3013857, NPL3013858, NPL3013860, NPL3013861, NPL3013862, NPL3013863, NPL3013864, NPL3013865, NPL3013871, NPL3013875, NPL3013876, NPL3013877, NPL3013878, NPL3013879, NPL3013890, NPL3013895, NPL3013896, NPL3013897, NPL3013901, NPL3013903, NPL3013904, NPL3013905, NPL3013906, NPL3013913, NPL3013916, NPL3013920, NPL3013923, NPL3013931, NPL3013932, NPL3013933, NPL3013935, NPL3013936, NPL3013937, NPL3013938, NPL3013939, NPL3013940, NPL3013941, NPL3013942, NPL3013943, NPL3013944, NPL3013949, NPL3013952, NPL3013953, NPL3013954, NPL3013960, NPL3013961, NPL3013962, NPL3013963, NPL3013964, NPL3013965, NPL3013966, NPL3013967, NPL3013969, NPL3013970, NPL3013971, NPL3013979, NPL3014238, NPL3014289, NPL3014291, NPL3014296, NPL3014297, NPL3014298, NPL3014299, NPL3014304, NPL3014307, NPL3014309, NPL3014311, NPL3014315, NPL3014317, NPL3014319, NPL3014321, NPL3014322, NPL3014323, NPL3014324, NPL3014326, NPL3014328, NPL3014330, NPL3014334, NPL3014335, NPL3014340, NPL3014343, NPL3014344, NPL3014457, NPL3014459, NPL3014462, NPL3014466, NPL3014467, NPL3014468, NPL3014521, NPL3014522, NPL3014526, NPL3014543, NPL3014544, NPL3014546, NPL3014573, NPL3014574, NPL3014575, NPL3014580, NPL3014584, NPL3014586, NPL3014588, NPL3014629, NPL3014630, NPL3014638, NPL3014770, NPL3014771, NPL3014772, NPL3014773, NPL3014774, NPL3014775, NPL3014776, NPL3014777, NPL3014778, NPL3014782, NPL3014784, NPL3014785, NPL3014788, NPL3014789, NPL3014791, NPL3014792, NPL3014793, NPL3014794, NPL3014796, NPL3014798, NPL3014799, NPL3014800, NPL3014869, NPL3014886, NPL3014887, NPL3014888, NPL3014889, NPL3014891, NPL3014892, NPL3014895, NPL3014971, NPL3014974, NPL3014975, NPL3014976, NPL3014977, NPL3014978, NPL3014980, NPL3014984, NPL3014988, NPL3014989, NPL3014990, NPL3014991, NPL3014997, NPL3015001, NPL3015005, NPL3015006, NPL3015007, NPL3015008, NPL3015010, NPL3015011, NPL3015014, NPL3015018, NPL3015071, NPL3015072, NPL3015074, NPL3015075, NPL3015076, NPL3015077, NPL3015078, NPL3015079, NPL3015081, NPL3015082, NPL3015083, NPL3015085, NPL3015086, NPL3015087, NPL3015088, NPL3015090, NPL3015091, NPL3015094, NPL3015095, NPL3015096, NPL3015097, NPL3015098, NPL3015099, NPL3015100, NPL3015101, NPL3015105, NPL3015107, NPL3015112, NPL3015113, NPL3015114, NPL3015116, NPL3015127, NPL3015128, NPL3015139, NPL3015140, NPL3015141, NPL3015142, NPL3015143, NPL3015144, NPL3015145, NPL3015146, NPL3015147, NPL3015148, NPL3015149, NPL3015150, NPL3015151, NPL3015152, NPL3015153, NPL3015154, NPL3015155, NPL3015156, NPL3015158, NPL3015160, NPL3015161, NPL3015162, NPL3015165, NPL3015166, NPL3015167, NPL3015168, NPL3015169, NPL3015170, NPL3015171, NPL3015178, NPL3015179, NPL3015184, NPL3015186, NPL3015187, NPL3015188, NPL3015189, NPL3015190, NPL3015261, NPL3015264, NPL3015266, NPL3015267, NPL3015270, NPL3015274, NPL3015275, NPL3015277, NPL3015278, NPL3015279, NPL3015310, NPL3015384, NPL3015385, NPL3015386, NPL3015387, NPL3015388, NPL3015389, NPL3015390, NPL3015391, NPL3015392, NPL3015393, NPL3015394, NPL3015396, NPL3015398, NPL3015399, NPL3015401, NPL3015402, NPL3015403, NPL3015404, NPL3015405, NPL3015406, NPL3015407, NPL3015512, NPL3015559, NPL3015561, NPL3015565; (2) GTIN 00763000094027, Serial Numbers: NPL3000006, NPL3000007, NPL3000009, NPL3000010, NPL3000011, NPL3000012, NPL3000014, NPL3000016, NPL3000017, NPL3000018, NPL3000021, NPL3000023, NPL3000025, NPL3000026, NPL3000029, NPL3000030, NPL3000031, NPL3000033, NPL3000035, NPL3000040, NPL3000043, NPL3000046, NPL3000047, NPL3000048, NPL3000049, NPL3000050, NPL3000055, NPL3000057, NPL3000059, NPL3000062, NPL3000063, NPL3000068, NPL3000071, NPL3000074, NPL3000076, NPL3000077, NPL3000079, NPL3000083, NPL3000093, NPL3000094, NPL3000097, NPL3000103, NPL3000105, NPL3000109, NPL3000111, NPL3000125, NPL3000128, NPL3000129, NPL3000134, NPL3000135, NPL3000143, NPL3000184, NPL3000186, NPL3000188, NPL3000189, NPL3000196, NPL3000197, NPL3000198, NPL3000199, NPL3000202, NPL3000203, NPL3000205, NPL3000206, NPL3000208, NPL3000209, NPL3000210, NPL3000212, NPL3000213, NPL3000214, NPL3000215, NPL3000216, NPL3000219, NPL3000220, NPL3000221, NPL3000222, NPL3000223, NPL3000224, NPL3000226, NPL3000227, NPL3000229, NPL3000230, NPL3000232, NPL3000233, NPL3000236, NPL3000237, NPL3000240, NPL3000241, NPL3000242, NPL3000246, NPL3000248, NPL3000249, NPL3000250, NPL3000252, NPL3000253, NPL3000255, NPL3000258, NPL3000259, NPL3000260, NPL3000261, NPL3000262, NPL3000264, NPL3000265, NPL3002259, NPL3002261, NPL3002262, NPL3002263, NPL3002266, NPL3002270, NPL3002274, NPL3002282, NPL3002284, NPL3002288, NPL3002291, NPL3002293, NPL3002294, NPL3002296, NPL3002300, NPL3002304, NPL3002655, NPL3002659, NPL3002660, NPL3002661, NPL3002662, NPL3002663, NPL3002664, NPL3002665, NPL3002666, NPL3002667, NPL3002668, NPL3002669, NPL3002670, NPL3002671, NPL3002672, NPL3002673, NPL3002674, NPL3002675, NPL3002676, NPL3002677, NPL3002679, NPL3002680, NPL3002681, NPL3002682, NPL3002684, NPL3002685, NPL3002686, NPL3002687, NPL3002688, NPL3002691, NPL3002692, NPL3002693, NPL3002694, NPL3002696, NPL3002697, NPL3002699, NPL3002700, NPL3002701, NPL3002702, NPL3002703, NPL3002704, NPL3002705, NPL3002706, NPL3002707, NPL3002709, NPL3002710, NPL3002711, NPL3002712, NPL3002713, NPL3002715, NPL3002716, NPL3002717, NPL3002718, NPL3002719, NPL3002720, NPL3002721, NPL3002722, NPL3002723, NPL3002724, NPL3002725, NPL3002726, NPL3002727, NPL3002728, NPL3002729, NPL3002730, NPL3002731, NPL3002732, NPL3002733, NPL3002734, NPL3002736, NPL3002737, NPL3002738, NPL3002739, NPL3002741, NPL3002742, NPL3002743, NPL3002745, NPL3002746, NPL3002747, NPL3002749, NPL3002750, NPL3002751, NPL3002752, NPL3002753, NPL3002754, NPL3002755, NPL3002756, NPL3002757, NPL3002872, NPL3002873, NPL3002874, NPL3002875, NPL3002877, NPL3002878, NPL3002879, NPL3002880, NPL3002881, NPL3002882, NPL3002883, NPL3002884, NPL3002885, NPL3002887, NPL3002888, NPL3002891, NPL3002892, NPL3002894, NPL3002898, NPL3002899, NPL3002900, NPL3002901, NPL3002902, NPL3002904, NPL3002906, NPL3002907, NPL3002908, NPL3002909, NPL3002910, NPL3002911, NPL3002913, NPL3002914, NPL3002915, NPL3002918, NPL3002919, NPL3002922, NPL3002924, NPL3002925, NPL3002927, NPL3002928, NPL3002929, NPL3002935, NPL3002940, NPL3002941, NPL3002942, NPL3002949, NPL3002950, NPL3002954, NPL3002955, NPL3002960, NPL3002961, NPL3003298, NPL3003304, NPL3003308, NPL3003310, NPL3003311, NPL3003313, NPL3003315, NPL3003317, NPL3003319, NPL3003324, NPL3003331, NPL3003332, NPL3003334, NPL3003337, NPL3003338, NPL3003339, NPL3003342, NPL3003345, NPL3003346, NPL3003347, NPL3003353, NPL3003354, NPL3003355, NPL3003356, NPL3003357, NPL3003359, NPL3003694, NPL3003696, NPL3003704, NPL3003705, NPL3003708, NPL3003711, NPL3003712, NPL3003713, NPL3003715, NPL3003717, NPL3003718, NPL3003720, NPL3003723, NPL3003729, NPL3003730, NPL3003731, NPL3003735, NPL3003736, NPL3003737, NPL3003741, NPL3003742, NPL3003984, NPL3003987, NPL3003988, NPL3003989, NPL3003990, NPL3007387, NPL3007388, NPL3007390, NPL3007391, NPL3010714, NPL3010717, NPL3010721, NPL3010722, NPL3010724, NPL3010725, NPL3010726, NPL3010732, NPL3010735, NPL3010736, NPL3010739, NPL3010748, NPL3010750, NPL3010752, NPL3010753, NPL3010756, NPL3010758, NPL3010759, NPL3010760, NPL3010761, NPL3010764, NPL3010769, NPL3010770, NPL3010771, NPL3010772, NPL3010774, NPL3010779, NPL3011292, NPL3011296, NPL3011298, NPL3011304, NPL3011309, NPL3011310, NPL3011311, NPL3011313, NPL3011314, NPL3011316, NPL3011317, NPL3011319, NPL3011320, NPL3011323, NPL3011328, NPL3011329, NPL3011330, NPL3011331, NPL3011332, NPL3011333, NPL3011336, NPL3011338, NPL3011343, NPL3011344, NPL3011345, NPL3011346, NPL3011347, NPL3011349, NPL3011350, NPL3011352, NPL3011353, NPL3011357, NPL3011358, NPL3011362, NPL3011363, NPL3011365, NPL3014039, NPL3014040, NPL3014042, NPL3014043, NPL3014045, NPL3014052, NPL3014053, NPL3014054, NPL3014055, NPL3014056, NPL3014057, NPL3014058, NPL3014059, NPL3014061, NPL3014064, NPL3014065, NPL3014066, NPL3014070, NPL3014071, NPL3014072, NPL3014073, NPL3014074, NPL3014076, NPL3014079, NPL3014083, NPL3014085, NPL3014086, NPL3014087, NPL3014095, NPL3014096, NPL3014097, NPL3014098, NPL3014346, NPL3014347, NPL3014454, NPL3014455, NPL3014456, NPL3014501, NPL3014505, NPL3014506, NPL3014508, NPL3014529, NPL3014530, NPL3014537, NPL3014541, NPL3014542, NPL3017239, NPL3017240, NPL3017247, NPL3017252, NPL3017254, NPL3017257, NPL3017260, NPL3017265, NPL3017266, NPL3017267, NPL3017268, NPL3017269, NPL3017270, NPL3017272, NPL3017275, NPL3017284, NPL3017285, NPL3017286, NPL3017287, NPL3017289, NPL3017290, NPL3017932, NPL3017933, NPL3017991, NPL3017992, NPL3017993, NPL3018577, NPL3018578, NPL3018655, NPL3018709, NPL3018711, NPL3018715, NPL3018718, NPL3018719, NPL3018885, NPL3019477, NPL3019531, NPL3019532, NPL3019533, NPL3019534, NPL3019535, NPL3019537, NPL3019539, NPL3019541, NPL3019607, NPL3019660, NPL3019663, NPL3019664, NPL3019666, NPL3019668, NPL3019672, NPL3019677, NPL3019678, NPL3019769, NPL3020210, NPL3021261, NPL3021268, NPL3021270, NPL3021465, NPL3021466, NPL3021467, NPL3021468, NPL3021471, NPL3021479, NPL3021480, NPL3021481, NPL3021485, NPL3021487, NPL3021488, NPL3021490, NPL3021491, NPL3022395, NPL3022399; (3) GTIN 00763000421007, Serial Numbers: NPL3016404, NPL3016409, NPL3016410, NPL3016411, NPL3016418, NPL3016420, NPL3016421, NPL3016422, NPL3016423, NPL3016424, NPL3016428, NPL3016429, NPL3016431, NPL3016435, NPL3016436, NPL3016437, NPL3016438, NPL3016439, NPL3016440, NPL3016441, NPL3016443, NPL3016444, NPL3016446, NPL3016447, NPL3016448, NPL3016449, NPL3016457, NPL3016458, NPL3016460, NPL3016461, NPL3016464, NPL3016465, NPL3016469, NPL3016470, NPL3016475, NPL3016477, NPL3016478, NPL3016479, NPL3016481, NPL3016482, NPL3016484, NPL3016488, NPL3016492, NPL3016493, NPL3016495, NPL3016498, NPL3016499, NPL3016501, NPL3016502, NPL3016504, NPL3016507, NPL3016508, NPL3016513, NPL3016515, NPL3016516, NPL3016517, NPL3016518, NPL3016519, NPL3016522, NPL3016524, NPL3016525, NPL3016526, NPL3016527, NPL3016528, NPL3016529, NPL3016530, NPL3016531, NPL3016535, NPL3016536, NPL3016537, NPL3016539, NPL3016582, NPL3016584, NPL3016592, NPL3016594, NPL3016600, NPL3016601, NPL3016602, NPL3016603, NPL3016606, NPL3016607, NPL3016608, NPL3016613, NPL3016617, NPL3016621, NPL3016699, NPL3016702, NPL3016712, NPL3016713, NPL3016714, NPL3016715, NPL3016716, NPL3016737, NPL3016738, NPL3016743, NPL3016744, NPL3016745, NPL3016746, NPL3016747, NPL3016748, NPL3016749, NPL3016750, NPL3016757, NPL3016761, NPL3016762, NPL3016763, NPL3016765, NPL3016766, NPL3016775, NPL3016776, NPL3016778, NPL3016780, NPL3016784, NPL3016785, NPL3016787, NPL3016788, NPL3016790, NPL3016792, NPL3016793, NPL3016795, NPL3016796, NPL3016797, NPL3016798, NPL3016800, NPL3016801, NPL3016802, NPL3016933, NPL3016995, NPL3017043, NPL3017053, NPL3017201, NPL3017214, NPL3017221, NPL3017224, NPL3017231, NPL3017232, NPL3017303, NPL3017307, NPL3017308, NPL3017309, NPL3017310, NPL3017312, NPL3017313, NPL3017315, NPL3017316, NPL3017320, NPL3017324, NPL3017325, NPL3017333, NPL3017335, NPL3017344, NPL3017346, NPL3017347, NPL3017348, NPL3017349, NPL3017350, NPL3017367, NPL3017384, NPL3017392, NPL3017393, NPL3017402, NPL3017412, NPL3017414, NPL3017424, NPL3017425, NPL3017426, NPL3017427, NPL3017430, NPL3017431, NPL3017444, NPL3017506, NPL3017610, NPL3017611, NPL3017613, NPL3017614, NPL3017620, NPL3017625, NPL3017628, NPL3017629, NPL3017630, NPL3017654, NPL3017660, NPL3017662, NPL3017663, NPL3017664, NPL3017685, NPL3017686, NPL3017692, NPL3017693, NPL3017694, NPL3017695, NPL3017704, NPL3017705, NPL3017706, NPL3017707, NPL3017717, NPL3017726, NPL3017727, NPL3017739, NPL3017744, NPL3017748, NPL3017761, NPL3017767, NPL3017768, NPL3017769, NPL3017770, NPL3017771, NPL3017774, NPL3017779, NPL3017890, NPL3017891, NPL3017895, NPL3017897, NPL3017898, NPL3017900, NPL3017922, NPL3017924, NPL3017926, NPL3017927, NPL3017928, NPL3017942, NPL3017943, NPL3017944, NPL3017995, NPL3017996, NPL3017998, NPL3018002, NPL3018004, NPL3018005, NPL3018006, NPL3018007, NPL3018008, NPL3018009, NPL3018010, NPL3018011, NPL3018012, NPL3018013, NPL3018015, NPL3018016, NPL3018017, NPL3018018, NPL3018019, NPL3018020, NPL3018021, NPL3018022, NPL3018023, NPL3018024, NPL3018025, NPL3018026, NPL3018028, NPL3018045, NPL3018046, NPL3018048, NPL3018049, NPL3018050, NPL3018052, NPL3018053, NPL3018054, NPL3018058, NPL3018059, NPL3018062, NPL3018527, NPL3018528, NPL3018532, NPL3018534, NPL3018537, NPL3018538, NPL3018562, NPL3018563, NPL3018564, NPL3018579, NPL3018602, NPL3018607, NPL3018608, NPL3018609, NPL3018613, NPL3018614, NPL3018617, NPL3018619, NPL3018623, NPL3018626, NPL3018627, NPL3018657, NPL3018659, NPL3018677, NPL3018720, NPL3018721, NPL3018726, NPL3018727, NPL3018728, NPL3018729, NPL3018735, NPL3018736, NPL3018737, NPL3018743, NPL3018747, NPL3018748, NPL3018750, NPL3018751, NPL3018756, NPL3018757, NPL3018759, NPL3018760, NPL3018761, NPL3018762, NPL3018763, NPL3018765, NPL3018769, NPL3018775, NPL3018776, NPL3018777, NPL3018778, NPL3018780, NPL3018784, NPL3018792, NPL3018808, NPL3018809, NPL3018829, NPL3018830, NPL3018831, NPL3018832, NPL3018833, NPL3018834, NPL3018835, NPL3018836, NPL3018839,
Quantity Affected: 10165 units
Reason for Recall
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-08
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2201-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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