Model Number U226 recall: Software Issue
Model Number U226, VISIONIST CRT-P EL
Why was Model Number U226 recalled?
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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00802526559457, Serial numbers: 700333, 700335, 700342, 700344, 700346, 700347, 700352, 700364, 700372, 700386, 700388, 700390, 700391, 700425, 700426, 700427, 700428, 700429, 700437, 700448, 700455, 700460, 700461, 700464, 700490, 700498, 700500, 700520, 700538, 700539, 700570, 700587, 700591, 700638, 700653, 700665, 700676, 700693, 700700, 700702, 700704, 700705, 700707, 700708, 700711, 700718, 700720, 700722, 700735, 700736, 700755, 700759, 700765, 700768, 700774, 700782, 700790, 700794, 700796, 700809, 700817, 700830, 700870, 700874, 700879, 700881, 700882, 700883, 700887, 700889, 700903, 700905, 700908, 700911, 700917, 700925, 700935, 700940, 700950, 700951, 700959, 700968, 700970, 700978, 700980, 700984, 700988, 700990, 700991, 700994, 700997, 701005, 701008, 701017, 701019, 701023, 701032, 701038, 701048, 701071, 701083, 701091, 701096, 701097, 701100, 701108, 701116, 701117, 701122, 701127, 701136, 701140, 701141, 701142, 701146, 701147, 701148, 701151, 701153, 701154, 701161, 701165, 701166, 701167, 701174, 701178, 701181, 701182, 701183, 701187, 701192, 701197, 701199, 701201, 701203, 701207, 701212, 701217, 701240, 701242, 701247, 701249, 701252, 701255, 701256, 701318, 701320, 701321, 701330, 701334, 701335, 701342, 701349, 701356, 701425, 701427, 701439, 701440, 701446, 701447, 701448, 701462, 701490, 701510, 701511, 701517, 701525, 701528, 701529, 701532, 701537, 701538, 701539, 701543, 701547, 701550, 701551, 701556, 701559, 701562, 701563, 701564, 701589, 701590, 701597, 701603, 701607, 701631, 701643, 701647, 701649, 701661, 701662, 701664, 701685, 701686, 701690, 701691, 701696, 701703, 701709, 701714, 701715, 701722, 701723, 701727, 701729, 701732, 701735, 701736, 701741, 701745, 701750, 701756, 701758, 701768, 701769, 701771, 701772, 701778, 701783, 701789, 701790, 701799, 701803, 701807, 701817, 701818, 701826, 701827, 700890, 700907, 700928, 700929, 700936. GTIN 00802526559464, Serial numbers: 100006, 100009, 100011, 100012, 100013, 100014, 100016, 100017, 100018, 100019, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100032, 100034, 100035, 100038, 100039, 100042, 100044, 100045, 100046, 100048, 100049, 100050, 100052, 100053, 100054, 100055, 100058, 100059, 100061, 100062, 100063, 100066, 100067, 100068, 100069, 100070, 100073, 100075, 100076, 100077, 100081, 100087, 100089, 100092, 100094, 100095, 100096, 100098, 100100, 100101, 100102, 100105, 100107, 100108, 100109, 100111, 100112, 100113, 100116, 100117, 100118, 100120, 100123, 100124, 100126, 100127, 100128, 100129, 100132, 100133, 100134, 100135, 100136, 700002, 700003, 700004, 700006, 700007, 700008, 700010, 700011, 700012, 700013, 700014, 700015, 700018, 700019, 700020, 700021, 700023, 700024, 700025, 700026, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700042, 700044, 700045, 700048, 700050, 700051, 700052, 700053, 700054, 700056, 700057, 700058, 700059, 700060, 700061, 700063, 700065, 700066, 700067, 700068, 700071, 700072, 700074, 700075, 700076, 700077, 700081, 700082, 700083, 700084, 700087, 700088, 700089, 700090, 700091, 700092, 700093, 700094, 700095, 700096, 700098, 700099, 700101, 700102, 700103, 700106, 700107, 700108, 700111, 700114, 700118, 700120, 700121, 700122, 700124, 700125, 700126, 700132, 700135, 700137, 700139, 700140, 700141, 700142, 700143, 700145, 700146, 700147, 700149, 700151, 700153, 700154, 700155, 700156, 700159, 700163, 700164, 700167, 700168, 700169, 700170, 700171, 700172, 700183, 700184, 700186, 700187, 700191, 700192, 700193, 700194, 700199, 700201, 700207, 700209, 700210, 700211, 700212, 700213, 700214, 700215, 700216, 700218, 700220, 700225, 700226, 700227, 700229, 700230, 700231, 700237, 700239, 700240, 700241, 700245, 700246, 700247, 700249, 700264, 700265, 700267, 700268, 700269, 700270, 700275, 700276, 700277, 700280, 700286, 700287, 700288, 700289, 700291, 700292, 700293, 700296, 700298, 700301, 700304, 700306, 700309, 700311, 700312, 700313, 700314, 700316, 700321, 700326, 700327, 700328, 700329, 700331, 700340, 700343, 700357, 700363, 700375, 700376, 700378, 700379, 700380, 700382, 700393, 700394, 700395, 700397, 700400, 700401, 700402, 700404, 700405, 700406, 700411, 700413, 700415, 700417, 700419, 700421, 700423, 700433, 700435, 700439, 700442, 700446, 700449, 700453, 700454, 700456, 700457, 700466, 700467, 700470, 700471, 700473, 700474, 700476, 700477, 700478, 700479, 700480, 700482, 700485, 700487, 700492, 700493, 700494, 700495, 700496, 700499, 700502, 700507, 700508, 700509, 700510, 700517, 700521, 700526, 700527, 700528, 700530, 700534, 700536, 700537, 700542, 700546, 700548, 700551, 700553, 700555, 700556, 700557, 700558, 700559, 700560, 700561, 700563, 700564, 700566, 700567, 700574, 700575, 700576, 700577, 700579, 700580, 700581, 700582, 700584, 700585, 700588, 700590, 700593, 700594, 700595, 700596, 700597, 700599, 700603, 700604, 700605, 700610, 700611, 700612, 700613, 700615, 700616, 700617, 700618, 700619, 700620, 700622, 700623, 700625, 700627, 700629, 700630, 700640, 700654, 700656, 700659, 700660, 700667, 700670, 700672, 700673, 700678, 700679, 700682, 700687, 700689, 700695, 700697, 700709, 700724, 700725, 700737, 700739, 700767, 700780, 700811, 700812, 700824, 700827, 700828, 700829, 700834, 700836, 700838, 700845, 700855, 700858, 700862, 700865, 700868, 700869, 700875, 700877, 700894, 700897, 700900, 700904, 700910, 700916, 700921, 700923, 700924, 700926, 700931, 700938, 700945, 700949, 700957, 700958, 700973, 700976, 700977, 700981, 700982, 700983, 700985, 700986, 700987, 700992, 701000, 701006, 701011, 701015, 701031, 701033, 701037, 701040, 701045, 701068, 701073, 701074, 701076, 701077, 701081, 701082, 701086, 701087, 701090, 701098, 701099, 701101, 701112, 701113, 701115, 701120, 701124, 701128, 701133, 701149, 701150, 701156, 701157, 701158, 701159, 701162, 701163, 701164, 701168, 701170, 701173, 701175, 701177, 701179, 701186, 701188, 701193, 701195, 701200, 701202, 701204, 701206, 701210, 701211, 701213, 701216, 701221, 701222, 701225, 701228, 701229, 701231, 701232, 701236, 701261, 701262, 701264, 701265, 701266, 701267, 701268, 701270, 701275, 701277, 701278, 701279, 701280, 701283, 701284, 701287, 701288, 701291, 701292, 701294, 701296, 701297, 701299, 701300, 701301, 701304, 701305, 701307, 701308, 701310, 701315, 701329, 701333, 701340, 701347, 701351, 701359, 701361, 701363, 701364, 701367, 701374, 701375, 701376, 701387, 701389, 701395, 701402, 701404, 701405, 701407, 701409, 701410, 701411, 701413, 701416, 701422, 701428, 701430, 701431, 701432, 701436, 701444, 701454, 701456, 701460, 701464, 701466, 701469, 701471, 701483, 701497, 701500, 701501, 701502, 701504, 701506, 701507, 701509, 701512, 701513, 701514, 701515, 701518, 701522, 701524, 701527, 701533, 701540, 701541, 701544, 701546, 701548, 701549, 701553, 701557, 701565, 701566, 701567, 701569, 701572, 701575, 701577, 701578, 701579, 701580, 701581, 701583, 701585, 701586, 701588, 701593, 701594, 701595, 701596, 701598, 701599, 701600, 701602, 701610, 701611, 701613, 701614, 701615, 701618, 701619, 701620, 701621, 701624, 701627, 701628, 701629, 701634, 701637, 701638, 701644, 701645, 701650, 701653, 701654, 701655, 701658, 701659, 701660, 701665, 701666, 701667, 701668, 701669, 701670, 701671, 701674, 701676, 701677, 701678, 701679, 701681, 701683, 701695, 701697, 701698, 701699, 701700, 701701, 701706, 701710, 701711, 701718, 701719, 701724, 701725, 701726, 701734, 701737, 701746, 701749, 701754, 701759, 701761, 701763, 701765, 701767, 701770, 701773, 701774, 701775, 701776, 701777, 701779, 701780, 701785, 701787, 701788, 701791, 701796, 701801, 701804, 701805, 701809, 701812, 701820, 701821. GTIN 00802526577123, Serial numbers: 100074, 100085, 100106, 700079, 700109, 700110, 700123, 700219, 700222, 700232, 700266, 700278, 700279, 700282, 700290, 700300, 700302, 700305, 700310, 700323, 700325, 700366, 700458, 700503, 700543, 700608, 700651, 700662, 700688, 700692, 700694, 700764, 700798, 700805, 700810, 700833, 700837, 700839, 700840, 700848, 700852, 700854, 700856, 700857, 700863, 700867, 700896, 700898, 700934, 700955, 700995, 701095, 701103, 701205, 701208, 701209, 701282, 701285, 701289, 701293, 701302, 701314, 701420, 701426, 701434, 701474, 701487, 701493, 701498, 701499, 701503, 701508, 701520, 701526, 701531, 701535, 701558, 701560, 701573, 701574, 701606, 701625, 701640, 701672, 701682, 701687, 701713, 701720, 701728, 701744, 701755, 701808, 701823.
- Product
- Model Number U226, VISIONIST CRT-P EL
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1,050 units
- Distribution
- Worldwide
- Recall date
- October 22, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)