Boston Scientific Corporation: Model Number U226, VISIONIST CRT-P EL

Recall number

Z-0104-2026

Recalling firm

Boston Scientific Corporation

Product

Model Number U226, VISIONIST CRT-P EL

Status

Open, Classified

Initiated

2025-08-20

Posted

2025-10-10

Terminated

not on file

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 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).

Root cause

Other

Action

Boston Scientific issued an "Urgent Medical Device Correction" notice to its customers on 08/18/2025 via letter. The notice provides an update to the December 2024 customer communication regarding the potential for the ACCOLADE family of pacemakers to initiate Safety Mode due to a high battery impedance state and contains recommendations timely upgrade of pacemaker software to prevent the occurrence of Safety Mode in an ambulatory setting. On 09/05/2025 an update to the 08/18/2025 notice (via letter), superseding the prior notice to address two unintended behaviors associated with the Model 3869 v2.04 software (designed to prevent potential initiation of Safety Mode due to a high battery impedance condition). The behaviors are: 1. Incomplete disablement of wandless automatic telemetry after detecting a high battery impedance condition. If an ACCOLADE family device with an elevated battery impedance induced Code-1003 remains in service, the software s new telemetry activated battery test is designed to continue assessing battery impedance and disable all wandless telemetry operation before high impedance is achieved and device resets can initiate Safety Mode. 2. Potential for the software s new daily battery test to misinterpret measurements in the presence of a magnet, initiating a false positive response that results in disablement of wandless telemetry sessions. For patients monitored via LATITUDE, this will trigger an alert message indicating an erroneous explant indicator (e.g., explant indicator was reached January 1, 2000) if the device had not previously reached replacement indication, stating that LATITUDE is no longer available, and prompting to contact Technical Services. Patients were notified regarding battery performance. Advisory is published at www.BostonScientific.com/advisory. If you have any questions, contact US Technical Services at 1.800.CARDIAC (227.3422) or email to: tech.services@bsci.com.

Quantity

1,050 units

Distribution

Worldwide

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P030005"]

Product code

NKE

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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