Model Number L209 PROPONENT DR (VDD) SL Pacemaker

Summary

The FDA issued a Class I for Model Number L209 PROPONENT DR (VDD) SL Pacemaker 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

Model Number L209 PROPONENT DR (VDD) SL Pacemaker

Lot/Code Info: GTIN 00802526559068, Serial Numbers: 100002, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100017, 100019, 100020, 100021, 100022, 100023, 100025, 100026, 100027, 100028, 100029, 100030, 100031, 100032, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100121, 100123, 100124, 100125, 100126, 100127, 100128, 100129, 100130, 100131, 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GTIN 00802526576386, Serial Numbers: 700401, 700406, 700408, 700422, 700431, 700432, 700445, 700459, 700462, 700466, 700474, 700477, 700478, 700484, 700513, 700522, 700525, 700526, 700527, 700538, 700539, 700543, 700546, 700668, 700692, 700694, 700704, 700706, 700708, 700710, 700711, 700712, 700719, 700720, 700721, 700722, 700723, 700726, 700732, 700733, 700734, 700735, 700739, 700740, 700743, 700745, 700758, 700762, 700767, 700784, 700811, 700819, 700822, 700839, 700840, 700841, 700844, 700866, 700867, 700869, 700874, 700875, 700876, 700877, 700878, 700879, 700880, 700882, 700886, 700892, 700913, 700923, 700925, 700926, 700930, 700934, 700937, 700939, 700946, 700954, 700955, 700957, 700961, 700963, 700965, 700967, 700969, 700975, 700978, 700980, 700987, 700989, 700991, 700994, 700997, 700998, 701004, 701005, 701008, 701010, 701016, 701020, 701023, 701026, 701030, 701034, 701036, 701048, 701049, 701051, 701062, 701065, 701075, 701096, 701098, 701106, 701108, 701113, 701119, 701123, 701124, 701125, 701145, 701149, 701152, 701153, 701191, 701192, 701198, 701200, 701207, 701210, 701339, 701340, 701346, 701354, 701362, 701368, 701369, 701379, 701387, 701393, 701394, 701395, 701397, 701401, 701402, 701415, 701416, 701419, 701422, 701427, 701429, 701430, 701433, 701435, 701438, 701439, 701442, 701446, 701452, 701454, 701458, 701462, 701465, 701469, 701471, 701473, 701476, 701477, 701481, 701491, 701492, 701497, 701499, 701505, 701511, 701515, 701521, 701522, 701524, 701532, 701539, 701551, 701572, 701574, 701582, 701587, 701589, 701591, 701593, 701597, 701598, 701600, 701601, 701603, 701607, 701611, 701618, 701621, 701626, 701632, 701636, 701639, 701640, 701655, 701661, 701672, 701674, 701678, 701682, 701684, 701687, 701688, 701689, 701691, 701692, 701693, 701700, 701704, 701705, 701706, 701709, 701710, 701711, 701714, 701715, 701716, 701717, 701719, 701720, 701721, 701722, 701729, 701746, 701814, 701818, 701819, 701821, 701822, 701823, 701832, 701834, 701836, 701838, 701841, 701848, 701854, 701860, 701861, 701862, 701863, 701867, 701870, 701874, 701879, 701880, 701881, 701884, 701891, 701895, 701896, 701898, 701913, 701919, 701928, 701932, 701934, 701936, 701937, 701946, 701947, 701952, 701955, 701956, 701958, 701959, 701960, 701962, 701964, 701965, 701966, 701967, 701968, 701969, 701970, 701971, 701973, 701988, 701992, 701993, 701996, 702006, 702013, 702014, 702024, 702025, 702028, 702030, 702031, 702032, 702033, 702057, 702059, 702062, 702078, 702082, 702084, 702115, 702121, 702128, 702129, 702131, 702138, 702139, 702147, 702148, 702149, 702154, 702156, 702157, 702158, 702159, 702161, 702162, 702163, 702164, 702169, 702173, 702174, 702175, 702176, 702178, 702179, 702180, 702247, 702248, 702250, 702251, 702252, 702253, 702254, 702257, 702261, 702262, 702263, 702265, 702266, 702267, 702268, 702269, 702277, 702279, 702280, 702282, 702290, 702294, 702301, 702304, 702306, 702309, 702311, 702312, 702325, 702330, 702335, 702337, 702345, 702346, 702349, 702350, 702351, 702352, 702354, 702355, 702358, 702360, 702361, 702362, 702363, 702364, 702365, 702366, 702367, 702368, 702371, 702372, 702373, 702375, 702376, 702377, 702379, 702380, 702381, 702382, 702383, 702384, 702385, 702386, 702387, 702388, 702389, 702390, 702392, 702393, 702394, 702395, 702396, 702397, 702398, 702399, 702400, 702402, 702403, 702404, 702405, 702406, 702407, 702408, 702409, 702410, 702411, 702412, 702413, 702523, 702536, 702540, 702542, 702549, 702551, 702552, 702553, 702564, 702566, 702567, 702568, 702571, 702578, 702604, 702605, 702606, 702607, 702608, 702610, 702611, 702612, 702614, 702615, 702616, 702618, 702619, 702620, 702621, 702622, 702623, 702665, 702667, 702669, 702670, 702694, 702698, 702699, 702700, 702701, 702706, 702707, 702708, 702710, 702711, 702712, 702713, 702727, 702767, 702772, 702774, 702775, 702776, 702777, 702778, 702779, 702780, 702781, 702782, 702783, 702784, 702785, 702787, 702788, 702790, 702791, 702792, 702793, 702794, 702797, 702802, 702803, 702805, 702813, 702815, 702816, 702820, 702825, 702830, 702831, 702834, 702867, 702870, 702887, 702890, 702891, 702906, 702914, 702918, 702922, 702923, 702944, 702983, 703024, 703027, 703035, 703042, 703043, 703044, 703069, 703070, 703075, 703077, 703085, 703091, 703103, 703106, 703113, 703114, 703115, 703124, 703127, 703132, 703141, 703145, 703146, 703149, 703155, 703159.

Quantity Affected: 3146 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