🔍 RecallPedia

Model Number U226, VISIONIST CRT-P EL

Class I - Dangerous
🏥 Medical Devices Recalled: August 20, 2025 Boston Scientific Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Scientific Corporation
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Model Number U226, VISIONIST CRT-P EL

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0104-2026

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Class I - Dangerous

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).

Aug 20, 2025 Other Medical Devices View Details →