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VISIONIST CRT-P recallZ-0104-2026 · Boston Scientific Corporation · initiated Aug 20, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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).

FDA root cause category: Other

What the company is doing

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: [email protected].

Recall details

Recall number
Z-0104-2026
Status
Open, Classified
Initiated by the company
Aug 20, 2025
Posted by the FDA
Oct 10, 2025
Recalling firm
Boston Scientific Corporation
Quantity
1,050 units
Product code
NKE
FDA submissions
P030005
Distribution
Worldwide

Product description

Model Number U226, VISIONIST CRT-P EL

Code information (models, lots, serial numbers)

Show the full code information (9k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

8 devices cleared under P030005 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97467).

Sources and updates

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