PROPONENT DR SL (Model L201)

Summary

The FDA issued a Class I for PROPONENT DR SL (Model L201) by Boston Scientific Corporation. Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery .

Details

Product Description

PROPONENT DR SL (Model L201)

Lot/Code Info: GTIN 00802526559044, Serial Numbers: 760356, 760366, 760367, 760404, 760409, 760412, 760441, 760443, 760500. GTIN 00802526576379, Serial numbers: 767280. GTIN 00802526559051, Serial numbers: 767088, 799586. GTIN 00802526576379, Serial Numbers: 100164, 100165, 100174, 100186, 100243, 100767, 100800, 723990, 724576, 724581, 724583, 724597, 724612, 724614, 724616, 724619, 724620, 724640, 724644, 724645, 724654, 724658, 724663, 724664, 724665, 724666, 724670, 724671, 724698, 724700, 724701, 724703, 724724, 724731, 724732, 724733, 724747, 724752, 724753, 724756, 724765, 724766, 724768, 724770, 724773, 724774, 724781, 724785, 724786, 724797, 724807, 724809, 724810, 724811, 724812, 724813, 724814, 724815, 724816, 724817, 724820, 724823, 724826, 724829, 724833, 724869, 724950, 724958, 724974, 724975, 724977, 724980, 724981, 725647, 725651, 725705, 725711, 725734, 725742, 725749, 725774, 725775, 725787, 726012, 726021, 726027, 726030, 726077, 726083, 726100, 726115, 726129, 726151, 726160, 726176, 726178, 726197, 726202, 726255, 726268, 726278, 726385, 726393, 726425, 726489, 726529, 726546, 726552, 726563, 726569, 726576, 726580, 726596, 726600, 726637, 726650, 726708, 726710, 726717, 726718, 726723, 726733, 726736, 726747, 726791, 726806, 726822, 727141, 727202, 733301, 734188, 735930, 736415, 736900, 737251, 737289, 737295, 737979, 737999, 738250, 738466, 738516, 738537, 738571, 738601, 738617, 738692, 738706, 739854, 739903, 739919, 739927, 739980, 740026, 740088, 740090, 740099, 743253, 743301, 743383, 743454, 743456, 744006, 744019, 744022, 744026, 744029, 744030, 744033, 744050, 744053, 744056, 744057, 744060, 744072, 744078, 744090, 746102, 746341, 746374, 753828, 753928, 753999, 754447, 754459, 758922, 759048, 759138, 759174, 759392, 759429, 759434, 759437, 759524, 759529, 760210, 761632, 762336, 762356, 762499, 762509, 762548, 762549, 764563, 765812, 765865, 766827, 766840, 767280, 767281, 767282, 767284, 767291, 767326, 767349, 767744, 767797, 767963, 768117, 768153, 768243, 768261, 768276, 768282, 768283, 768286, 768295, 768296, 768314, 768608, 768656, 768739, 768752, 768786, 768814, 768836, 768849, 768905, 768999, 771813, 771819, 779667, 779978, 779986, 779993, 779994, 780001, 780074, 780123, 780142, 780144, 780165, 780199, 780270, 780292, 780306, 780308, 780330, 780332, 780335, 780336, 780813, 780864, 780871, 780872, 797686, 797691, 797710, 797713, 797718. GTIN 00802526576874, Serial numbers: 715757, 715779, 715795, 715799, 715805, 715842, 715905, 715993, 716005, 716044, 716045, 716063, 716066, 716148, 716182, 716190, 716208, 716250, 716292, 716306, 716315, 716423, 716514, 716543, 716610, 716629, 716680, 716715, 716721, 716759, 716779, 716803, 717000, 717018, 717053, 717070, 717098, 717099, 717108, 717153, 717156, 717166, 717197, 717302, 717306, 717313, 717369, 717378, 717413, 717593, 717600, 717700, 717816, 717878, 717896, 717906, 717931, 717963, 717994, 717996, 718005, 718137, 718418, 718494, 718504, 718528, 718552, 718601, 718605, 718608, 718617, 718627, 718630, 718631, 718640, 718659, 718667, 718668, 718675, 718697, 718711, 718713, 718716, 718733, 718762, 718778, 718784, 718794, 718801, 718805, 718806, 718820, 718833, 718881, 718882, 718890, 718892, 718893, 718894, 718896, 718900, 718908, 718914, 718972, 718989, 719045, 724678, 724683, 724783, 724818, 725894, 725949, 736403, 737513, 737926, 737997, 738014, 738721, 738746, 738764, 738794, 738825, 738834, 738836, 739420, 739936, 740178, 740375, 741218, 741219, 741287, 741696, 741730, 741970, 742033, 742045, 742079, 742107, 742206, 742209, 742215, 742267, 742274, 742295, 742324, 742331, 742337, 742435, 742443, 742444, 742475, 742491, 742532, 742566, 742606, 742607, 742613, 742614, 742620, 742621, 742640, 742667, 742815, 742849, 742858, 742866, 742878, 742885, 742931, 742960, 742985, 743012, 743064, 743086, 743093, 743102, 743137, 743141, 743205, 743343, 743353, 743362, 743985, 743989, 744018, 744028, 744048, 744051, 744071, 744087, 745089, 745110, 745704, 745739, 745754, 745805, 745827, 745833, 745858, 745878, 745881, 745888, 745904, 745907, 745909, 745910, 745911, 745915, 745916, 745922, 745935, 745936, 745942, 745945, 745946, 745948, 745950, 745954, 745959, 745960, 745964, 745965, 745966, 745971, 745972, 745975, 745977, 745987, 746011, 746018, 746021, 746030, 746034, 746035, 746047, 746050, 746051, 746058, 746059, 746062, 746065, 746066, 746067, 746068, 746069, 746073, 746076, 746079, 746082, 746086, 746089, 746093, 746096, 746103, 746115, 746117, 746122, 746124, 746125, 746144, 746152, 746189, 746248, 746257, 746368, 746376, 746389, 750690, 751125, 751479, 752229, 752296, 752312, 752409, 752607, 752660, 752676, 752894, 752929, 753368, 753857, 754853, 754863, 754866, 754876, 754878, 754882, 754884, 754939, 754946, 754961, 760408, 760539, 760542, 760544, 760548, 760549, 760553, 760832, 760860, 760870, 760881, 760939, 761502, 761519, 761570, 763356, 763704, 763987, 764009, 764040, 764047, 764054, 764055, 764074, 764079, 764080, 764087, 764088, 764089, 764098, 764099, 764101, 764109, 764126, 764127, 764135, 764147, 764149, 764166, 764171, 764201, 764280, 764321, 764404, 764470, 766207, 766216, 781345, 781358, 781386, 781394, 781397, 781411, 781415, 781417, 781432, 781440, 781931, 781942, 782015, 782019, 782026, 782037, 782075, 782076, 782088, 782091, 782095, 782099, 782112, 782113, 782115, 782120, 782122, 782133, 782144, 782145, 782151, 782153, 782179, 782180, 782184, 782233, 782245, 782253, 782264, 782275, 782315, 782326, 782327, 782329, 782330, 782352, 782357, 782365, 782367, 782378, 782382, 782392, 782395, 782399, 782410, 782434, 782470, 782473, 782475, 782477, 782479, 782483, 782485, 782491, 782501, 782504, 782506, 782661, 782664, 782668, 782669, 782670, 782671. GTIN 00802526578014, Serial Numbers: 100140, 100181, 100221, 100282, 100287, 100290, 100401, 100407, 100410, 100707, 100750, 100763, 100766, 100770, 100772, 100781, 100782, 100783, 100785, 100786, 100788, 100793, 100803, 100804, 100808, 100818, 100827, 100838, 100839, 713123, 714640, 714796, 715611, 715802, 715831, 715847, 715854, 715886, 715907, 715912, 715934, 715949, 715953, 715981, 715986, 715991, 716002, 716007, 716011, 716016, 716028, 716054, 716081, 716093, 716097, 716106, 716107, 716108, 716147, 716162, 716163, 716171, 716183, 716194, 716205, 716228, 716237, 716239, 716247, 716255, 716256, 716260, 716267, 716282, 716288, 716289, 716290, 716291, 716309, 716317, 716333, 716342, 716346, 716360, 716375, 716380, 716396, 716407, 716410, 716419, 716421, 716424, 716426, 716433, 716435, 716443, 716455, 716473, 716545, 716572, 716605, 716641, 716727, 716750, 716760, 716769, 716836, 716839, 716841, 716845, 716868, 716990, 716994, 716997, 717009, 717034, 717040, 717077, 717083, 717118, 717124, 717182, 717189, 717248, 717250, 717274, 717310, 717314, 717491, 717504, 717525, 717533, 717570, 717577, 717583, 717653, 717877, 717885, 717917, 717978, 717991, 718021, 718242, 718492, 718558, 718600, 718672, 718676, 718680, 718683, 718705, 718743, 718747, 718748, 718775, 718807, 718831, 718852, 718860, 718868, 718883, 718901, 718915, 718931, 718979, 718990, 719003, 719014, 719016, 719948, 726436, 726496, 726688, 726728, 726790, 732778, 732794, 732809, 732914, 732938, 732999, 733010, 733190, 733409, 733459, 733865, 734565, 734585, 735202, 735235, 735527, 736577, 736898, 737265, 737344, 737419, 737481, 737625, 737659, 737953, 738195, 738328, 738332, 738356, 738449, 738482, 738638, 738656, 738684, 738690, 738691, 738708, 738724, 738730, 738745, 738788, 738839, 739422, 739807, 740058, 740206, 741222, 741234, 741241, 741242, 741307, 741396, 741404, 741408, 741663, 741837, 741928, 741986, 742029, 742031, 742141, 742216, 742235, 742256, 742265, 742270, 742281, 742297, 742333, 742343, 742359, 742372, 742379, 742390, 742402, 742436, 742451, 742461, 742514, 742520, 742536, 742548, 742556, 742588, 742618, 742625, 742677, 742746, 742748, 742754, 742932, 743073, 743106, 743107, 743187, 743229, 743328, 743372, 743384, 743397, 743460, 743461, 743462, 743477, 743535, 743755, 743858, 743915, 743983, 743988, 744020, 744025, 744027, 744037, 744040, 744046, 744049, 744052, 744054, 744061, 744068, 744070, 744073, 744076, 744079, 744081, 744083, 745215, 745469, 745477, 745618, 745638, 745674, 745695, 745729, 745733, 745734, 745736, 745740, 745741, 745752, 745756, 745761, 745764, 745768, 745770, 745782, 745786, 745791, 745792, 745799, 745809, 745834, 745845, 745851, 745853, 745859, 745869, 745875, 745882, 745883, 745885, 745887, 745889, 745896, 745901, 745903, 745906, 745913, 745914, 745918, 745919, 745921, 745923, 745934, 745937, 745940, 745947, 745949, 745956, 745962, 745973, 745974, 745976, 745978, 745979, 745980, 745985, 745990, 745995, 745999, 746001, 746002, 746003, 746005, 746007, 746008, 746010, 746013, 746023, 746025, 746026, 746027, 746028, 746033, 746036, 746041, 746042, 746043, 746044, 746046, 746049, 746052, 746056, 746061, 746064, 746072, 746074, 746077, 746078, 746081, 746083, 746085, 746087, 746088, 746090, 746092, 746094, 746095, 746097, 746098, 746100, 746101, 746107, 746114, 746116, 746118, 746119, 746120, 746121, 746123, 746126, 746130, 746131, 746136, 746145, 746285, 746293, 746308, 746320, 746322, 746346, 746443, 746451, 746453, 750039, 750814, 750828, 750843, 750856, 750893, 751443, 751482, 751488, 751497, 751524, 751532, 751576, 751579, 751586, 751587, 751589, 751591, 751592, 751612, 751616, 751629, 751637, 751646, 751647, 751648, 751652, 751668, 751674, 751699, 751724, 751731, 751775, 751793, 751799, 751939, 751972, 751975, 751976, 751983, 751985, 751987, 751988, 751989, 751991, 751992, 751994, 751996, 751997, 751998, 751999, 752000, 752002, 752004, 752009, 752010, 752012, 752013, 752020, 752021, 752022, 752024, 752026, 752027, 752028, 752031, 752032, 752033, 752034, 752040, 752041, 752045, 752049, 752050, 752051, 752052, 752055, 752056, 752058, 752061, 752063, 752064, 752066, 752068, 752070, 752071, 752076, 752078, 752079, 752080, 752087, 752105, 752110, 752125, 752128, 752166, 752178, 752180, 752202, 752207, 752234, 752236, 752261, 752274, 752297, 752349, 752406, 752407, 752585, 752661, 752709, 752720, 752738, 752747, 752770, 753820, 753997, 754397, 762500, 762514, 762519, 762524, 762590, 762602, 762623, 762624, 762641, 762679, 762684, 763062, 763176, 763177, 763220, 763231, 763232, 763235, 763279, 763311, 763321, 763347, 763585, 763634, 763682, 763711, 764174, 764187, 764192, 764237, 764250, 764486, 764499, 765795, 765815, 765821, 765822, 765826, 765827, 765828, 765829, 765920, 766836, 766841, 767254, 767405, 768140, 768287, 768628, 768630, 768643, 768677, 768784, 768908, 768910, 768911, 770146, 770164, 770230, 773153, 773170, 773373, 773742, 775037, 775084, 775144, 775741, 775959, 775964, 775974, 775975, 775995, 775998, 776038, 776514, 776559, 776606, 779977, 779979, 779981, 779982, 779983, 779984, 780014, 780046, 780087, 780098, 780110, 780125, 780140, 780167, 780176, 781317, 781363, 781489, 781532, 781536, 781588, 781589, 781590, 781593, 781595, 781600, 781601, 781602, 781607, 781608, 781613, 781614, 781615, 781617, 781619, 781622, 781623, 781627, 781628, 781629, 781634, 781636, 781645, 781647, 781648, 781653, 781656, 781659, 781660, 781661, 781663, 781665, 781666, 781667, 781668, 781671, 781674, 781684, 781685, 781686, 781693, 781701, 781704, 781705, 781706, 781707, 781708, 781711, 781712, 781713, 781717, 781723, 781724, 781726, 781729, 781732, 781733, 781736, 781737, 781738, 781740, 781741, 781742, 781743, 781745, 781748, 781749, 781750, 781753, 781757, 781759, 781762, 781764, 781765, 781778, 781784, 781785, 781790, 781791, 781794, 781797, 781802, 781809, 781822, 781824, 781831, 781904, 782231, 782235, 782238, 782239, 782240, 782242, 782243, 782246, 782247, 782250, 782251, 782252, 782257, 782258, 782259, 782260, 782261, 782262, 782263, 782266, 782268, 782269, 782272, 782274, 782278, 782282, 782284, 782285, 782286, 782299, 782300, 782301, 782309, 782310, 782312, 782313, 782319, 782320, 782321, 782322, 782323, 782325, 782341, 782676, 782685, 782689, 782705, 782707, 782711, 782727, 782732, 783168, 783236, 783241, 783242, 783243, 783252, 783257, 783264, 783266, 783267, 783269, 783270, 783274, 783276, 783284, 783307, 783309, 783313, 783317, 783330, 783339, 783343, 783360, 783361, 783362, 783363, 783366, 783369, 783398, 783399, 783400, 783416, 783420, 783423, 783431, 783435, 783437, 783443, 783444, 783445, 783617, 783626, 783627, 783640, 783663, 783664, 783665, 783666, 783668, 783670, 783671, 783672, 783673, 783674, 783676, 783677, 783678, 783679, 783680, 783681, 783684, 783687, 783688, 783689, 783690, 783691, 783692, 783693, 783694, 783695, 783696, 783698, 783699, 783700, 783701, 783702, 783703, 783705, 783706, 783707, 783708, 783709, 783710, 783711, 783712, 783714, 783715, 783716, 783717, 783718, 783719, 783720, 783724, 783726, 783727, 783728, 783731, 783732, 783733, 783734, 783735, 783736, 784718, 784753, 784754, 784755, 784756, 784757, 784760, 784832, 784833, 784834, 784835, 784836, 784837, 784838, 784839, 784840, 784862, 784867, 784872, 784873, 784875, 784876, 784877, 784878, 784880, 784902, 784903, 784908, 784913, 785747, 785800, 785803, 785807, 785830, 785871, 785880, 785882, 785894, 785899, 785933, 785955, 787782, 787802, 787808, 787809, 787812, 787813, 787814, 787815, 787817, 787818, 787827, 787831, 787833, 787835, 787845, 787847, 787851, 787867, 787896, 787902, 787903, 787904, 787905, 787907, 787916, 787955, 787956, 787959, 788994, 789004, 789355, 789370, 789396, 789419, 789433, 789434, 789435, 789468, 789488, 789491, 789495, 789497, 789503, 789552, 789554, 789556, 789557, 789951, 789999, 790054, 790055, 790056, 790082, 790087, 790105, 790138, 790141, 790144, 790154, 790159, 790162, 790164, 790166, 790178, 790182, 790199, 790201, 790205, 790206, 790207, 790256, 790265, 790290, 790306, 790331, 790334, 790337, 790339, 790340, 790342, 790343, 790346, 790349, 790350, 790351, 790354, 790362, 790363, 790366, 790367, 790368, 790371, 790372, 790373, 790374, 790375, 790376, 790384, 790396, 790398, 790399, 790403, 790412, 790417, 790434, 790468, 790473, 790478, 790479, 790481, 790505, 790517, 790531, 790543, 790548, 790549, 790551, 790552, 790553, 790555, 790556, 790558, 790559, 790562, 790563, 790565, 790570, 790575, 790579, 790584, 790593, 790598, 790599, 790600, 790611, 790615, 790617, 790623, 790628, 790634, 790637, 790643, 790645, 790649, 790653, 790655, 790668, 790671, 790673, 790674, 790676, 790678, 790685, 790698, 790700, 790704, 790711, 790731, 790930, 791114, 791197, 791199, 791200, 791201, 791205, 791208, 791210, 791212, 791213, 791214, 791215, 791216, 791220, 791225, 791226, 791227, 791228, 791230, 791231, 791232, 791233, 791234, 791235, 791242, 791244, 791248, 791255, 791257, 791261, 791265, 791274, 791276, 791277, 791278, 791279, 791280, 791281, 791282, 791283, 791284, 791286, 791287, 791288, 791289, 791290, 791291, 791292, 791296, 791297, 791298, 791299, 791300, 791302, 791303, 791304, 791305, 791307, 791308, 791309, 791310, 791311, 791312, 791314, 791315, 791316, 791317, 791318, 791319, 791320, 791321, 791322, 791323, 791324, 791325, 791326, 791327, 791328, 791329, 791330, 791331, 791332, 791333, 791334, 791335, 791336, 791337, 791338, 791339, 791340, 791341, 791342, 791343, 791344, 791345, 791347, 791350, 791351, 791353, 791355, 791356, 791357, 791358, 791359, 791360, 791362, 791366, 791367, 791368, 791369, 791370, 791371, 791373, 791374, 791375, 791377, 791378, 791379, 791381, 791382, 791383, 791386, 791399, 791403, 791404, 791405, 791410, 791414, 791416, 791417, 791418, 791419, 791420, 791421, 791423, 791424, 791425, 791427, 791428, 791429, 791430, 791431, 791432, 791433, 791434, 791435, 791447, 791448, 791449, 791450, 791451, 791452, 791453, 791454, 791455, 791456, 791457, 791460, 791461, 791462, 791465, 791466, 791468, 791469, 791471, 791478, 791495, 791496, 791498, 791505, 791508, 791509, 791511, 791512, 791513, 791520, 791524, 791584, 791594, 791596, 791603, 791620, 791654, 791667, 791670, 791672, 791675, 791749, 791750, 791787, 791788, 791836, 791841, 791846, 791847, 791848, 791850, 791852, 791858, 791859, 791860, 792185, 792236, 792238, 792241, 792242, 792265, 792270, 792271, 792276, 792285, 792290, 792295, 792376, 792442, 792444, 792460, 792464, 792474, 792476, 792477, 792484, 792485, 792489, 792494, 792495, 792501, 792504, 793098, 793116, 793140, 793144, 793148, 793163, 793167, 793168, 793170, 793172, 793173, 793177, 793183, 793185, 793188, 793194, 793212, 793215, 793231, 793236, 793261, 793264, 793331, 793336, 793377, 793385, 793386, 793393, 793394, 793429, 793452, 793464, 793484, 793485, 793600, 793613, 793614, 793630, 793646, 793656, 793657, 793658, 793660, 793661, 793663, 793664, 793665, 793666, 793668, 793672, 793673, 793676, 793677, 793680, 793681, 793682, 793683, 793684, 793686, 793687, 793688, 793689, 793690, 793695, 793698, 793700, 793701, 793702, 793704, 793706, 793707, 793708, 793710, 793711, 793712, 793713, 793714, 793715, 793716, 793717, 793718, 793719, 793720, 793722, 793723, 793724, 793725, 793728, 793729, 793730, 793731, 793732, 793734, 793737, 793742, 793744, 793745, 793746, 793747, 793748, 793750, 793751, 793752, 793753, 793764, 793768, 793769, 793770, 793771, 793772, 793778, 793792, 793808, 795497, 795502, 795532, 795537, 795545, 795551, 795557, 795560, 795566, 795568, 795592, 795598, 795599, 795635, 795636, 795642, 795644, 795664, 795693, 795698, 795708, 795720, 795722, 795726, 795730, 795733, 795738, 795742, 795743, 795744, 795745, 795747, 795749, 795754, 795807, 795812, 795814, 795815, 795816, 795818, 795820, 795822, 795826, 795829, 795836, 795837, 795845, 795846, 795847, 795849, 795850, 795855, 795856, 795858, 795861, 795864, 795865, 795869, 795870, 795871, 795872, 795874, 795875, 795879, 795884, 795886, 795887, 795888, 795892, 795894, 795895, 795902, 795927, 797874, 797875, 797891, 797894, 797899, 797915, 797920, 797922, 797927, 797931, 797933, 797940, 797942, 797944, 797951, 797974, 798127, 798169, 798175, 798180, 798183, 798218, 798223, 798225, 798226, 798228, 798235, 798236, 798237, 798238, 798239, 798243, 798244, 798250, 798268, 798270, 798273, 798275, 798276, 798280, 798284, 798285, 798291, 798293, 798294, 798305, 798466, 798479, 798508, 798509, 798526, 798532, 798778, 798781, 798783, 798811, 798841, 798847, 798935, 799019, 799035, 799038, 799109, 799119, 799121, 799128, 799144, 799287, 799334, 799339, 799344, 799345, 799354, 799356, 799359, 799397, 799415, 799420, 799429, 799439, 799443, 799469, 799470, 799471, 799473, 799474, 799475, 799494, 799495, 799507, 799508, 799512, 799515, 799519, 799541, 799546, 799551, 799553, 799561, 799562, 799563, 799564, 799565, 799566, 799575, 799577, 799585, 799604, 799633, 799636, 800217, 800223, 800226, 800231, 800239, 800248, 800249, 800283, 800537, 800562, 800650, 800668, 800672, 801182, 801191, 801211, 801214, 801215, 801223, 801236, 801245, 801250, 801251, 801324, 801338, 801346, 801347, 801348, 801360, 801362, 801367, 801370, 801371, 801427, 801438, 801459, 801461, 801469, 801470, 801472, 801490, 801494, 801500, 801869, 801870, 801871, 801872, 801873, 801875, 801886, 801887, 801888, 801889, 801890, 801893, 801895, 802031, 802097, 802099, 802103, 802106, 802114, 802115, 802121, 802125, 802129, 802131, 802133, 802135, 802141, 802157, 802173, 802177, 802185, 802189, 802216, 802245, 802472, 802480, 802498, 802501, 802516, 802529, 802547, 802574, 802582, 802594, 802595, 802652, 802656, 803014, 803052, 803074, 803187, 803220, 803267, 803268, 803275, 803289, 803300, 803315, 803319, 803329, 803550, 803557, 803558, 803604, 803612, 803616, 803619, 803623, 803630, 803635, 803636, 803639, 803640, 803641, 803643, 803646, 803657, 803658, 803686, 803698, 803712.

Quantity Affected: 2,426 units

Reason for Recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Type: Voluntary: Firm initiated

Recall Initiated: 2025-08-20

Company