Class 2 Device Recall VISIONIST CRTP

• Date Initiated by Firm: June 03, 2021
• Date Posted: July 02, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2003-2021
• Recall Event ID: 88087
• PMA Number: P030005
• Product Classification: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
• Product: VISIONIST CRT-P pacemaker, Models:; a) U225; b) U226; c) U228
• Code Information: a) U225, Serial Numbers: 707340, 100094, 100142, 100152, 100160, 100184, 100309, 100364, 100807, 100880, 100908, 100913, 700015, 700197, 700469, 700559, 700563, 700576, 700586, 700598, 700613, 700655, 700681, 700682, 700722, 700725, 700782, 700824, 700895, 700942, 700961, 700998, 701017, 701030, 701045, 701094, 701118, 701127, 701212, 701230, 701264, 701336, 701339, 701343, 701407, 701477, 701504, 702448, 702462, 702471, 702654, 702673, 702685, 702809, 703137, 703696, 703697, 703784, 703827, 703875, 703883, 703998, 707324, 707337, 707338, 707347, 707348, 707398, 707430, 707477, 707502, 707503, 707505, 707510, 707511, 707512, 707522, 707524, 707538, 707546, 707566, 707587, 707590, 707597, 100016, 100021, 100023, 100048, 100053, 100059, 100060, 100061, 100064, 100065, 100070, 100072, 100073, 100075, 100077, 100082, 100087, 100088, 100089, 100090, 100093, 100097, 100098, 100100, 100101, 100103, 100105, 100107, 100108, 100109, 100113, 100114, 100115, 100116, 100117, 100118, 100120, 100121, 100122, 100123, 100125, 100126, 100128, 100129, 100130, 100131, 100134, 100135, 100137, 100138, 100140, 100143, 100144, 100145, 100147, 100151, 100153, 100154, 100155, 100156, 100161, 100168, 100169, 100170, 100172, 100173, 100174, 100176, 100181, 100183, 100185, 100186, 100187, 100190, 100191, 100195, 100196, 100197, 100198, 100233, 100238, 100241, 100252, 100266, 100269, 100271, 100273, 100276, 100278, 100282, 100289, 100293, 100296, 100304, 100312, 100313, 100316, 100388, 100395, 100398, 100424, 100428, 100471, 100543, 100545, 100579, 100581, 100595, 100602, 100604, 100610, 100616, 100627, 100712, 100717, 100720, 100734, 100747, 100787, 100800, 100804, 100806, 100810, 100819, 100827, 100828, 100832, 100834, 100835, 100845, 100849, 100850, 100851, 100852, 100853, 100856, 100858, 100865, 100874, 100879, 100887, 100888, 100889, 100890, 100892, 100894, 100895, 100900, 100901, 100902, 100905, 100906, 100907, 100909, 100915, 100916, 100917, 100919, 100921, 100922, 100923, 100924, 100926, 100928, 100929, 100930, 100931, 100932, 100933, 100934, 100935, 700002, 700006, 700013, 700016, 700021, 700024, 700025, 700027, 700035, 700039, 700040, 700043, 700044, 700047, 700048, 700052, 700056, 700060, 700063, 700064, 700067, 700071, 700075, 700077, 700080, 700082, 700083, 700084, 700085, 700088, 700089, 700092, 700094, 700099, 700100, 700102, 700103, 700104, 700105, 700108, 700109, 700110, 700115, 700121, 700125, 700128, 700132, 700134, 700138, 700142, 700145, 700146, 700148, 700151, 700152, 700153, 700155, 700156, 700157, 700159, 700160, 700165, 700170, 700180, 700188, 700189, 700198, 700202, 700203, 700205, 700206, 700209, 700210, 700211, 700214, 700215, 700216, 700217, 700221, 700222, 700225, 700246, 700249, 700268, 700271, 700274, 700278, 700279, 700281, 700285, 700288, 700291, 700292, 700389, 700425, 700427, 700428, 700429, 700430, 700431, 700432, 700433, 700434, 700435, 700446, 700447, 700448, 700449, 700450, 700451, 700452, 700453, 700454, 700455, 700457, 700458, 700459, 700461, 700462, 700463, 700464, 700465, 700467, 700468, 700470, 700471, 700472, 700473, 700474, 700475, 700476, 700477, 700478, 700479, 700480, 700481, 700482, 700483, 700484, 700485, 700486, 700487, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700498, 700499, 700500, 700503, 700504, 700506, 700508, 700510, 700511, 700512, 700513, 700514, 700515, 700516, 700522, 700523, 700524, 700525, 700526, 700527, 700528, 700529, 700530, 700531, 700532, 700533, 700534, 700535, 700536, 700537, 700538, 700540, 700541, 700542, 700543, 700544, 700545, 700546, 700547, 700548, 700549, 700550, 700551, 700553, 700555, 700558, 700560, 700561, 700562, 700564, 700566, 700567, 700568, 700570, 700571, 700572, 700573, 700574, 700575, 700577, 700578, 700579, 700580, 700581, 700583, 700584, 700585, 700587, 700588, 700590, 700591, 700592, 700593, 700594, 700595, 700596, 700597, 700599, 700600, 700603, 700604, 700605, 700606, 700607, 700608, 700609, 700610, 700611, 700612, 700614, 700615, 700616, 700617, 700620, 700622, 700623, 700624, 700625, 700626, 700627, 700628, 700629, 700631, 700632, 700633, 700635, 700636, 700637, 700639, 700640, 700641, 700642, 700643, 700644, 700645, 700647, 700648, 700651, 700652, 700653, 700654, 700658, 700659, 700660, 700661, 700663, 700664, 700665, 700666, 700667, 700668, 700670, 700671, 700672, 700673, 700674, 700676, 700677, 700679, 700680, 700683, 700684, 700686, 700687, 700688, 700689, 700690, 700691, 700693, 700694, 700695, 700696, 700698, 700699, 700704, 700705, 700710, 700711, 700712, 700714, 700715, 700716, 700717, 700718, 700719, 700720, 700723, 700724, 700727, 700728, 700729, 700730, 700731, 700732, 700733, 700734, 700736, 700737, 700739, 700740, 700741, 700742, 700743, 700745, 700748, 700749, 700750, 700751, 700752, 700753, 700754, 700755, 700756, 700757, 700758, 700760, 700761, 700764, 700766, 700767, 700768, 700770, 700772, 700773, 700774, 700775, 700776, 700778, 700779, 700780, 700781, 700783, 700785, 700788, 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701187, 701188, 701189, 701190, 701211, 701213, 701214, 701215, 701216, 701217, 701220, 701221, 701225, 701226, 701227, 701228, 701233, 701234, 701235, 701237, 701238, 701239, 701242, 701244, 701245, 701246, 701247, 701248, 701253, 701255, 701257, 701261, 701262, 701263, 701265, 701267, 701268, 701269, 701272, 701274, 701275, 701277, 701286, 701290, 701292, 701293, 701294, 701295, 701298, 701319, 701322, 701324, 701326, 701327, 701328, 701329, 701330, 701331, 701335, 701337, 701340, 701344, 701346, 701347, 701349, 701350, 701353, 701354, 701359, 701360, 701361, 701362, 701363, 701365, 701366, 701367, 701368, 701369, 701370, 701371, 701372, 701373, 701374, 701375, 701376, 701377, 701378, 701379, 701381, 701382, 701383, 701385, 701386, 701387, 701389, 701390, 701395, 701396, 701397, 701398, 701399, 701400, 701401, 701402, 701403, 701404, 701405, 701406, 701408, 701409, 701410, 701412, 701413, 701415, 701417, 701418, 701419, 701420, 701421, 701423, 701425, 701426, 701427, 701428, 701429, 701430, 701431, 701433, 701435, 701437, 701438, 701439, 701440, 701441, 701443, 701444, 701445, 701446, 701448, 701450, 701452, 701453, 701454, 701455, 701456, 701457, 701458, 701459, 701460, 701461, 701462, 701463, 701464, 701465, 701466, 701467, 701468, 701469, 701470, 701471, 701473, 701474, 701475, 701476, 701478, 701479, 701480, 701481, 701482, 701483, 701484, 701487, 701488, 701489, 701490, 701491, 701492, 701493, 701494, 701495, 701496, 701497, 701499, 701500, 701501, 701502, 701503, 701505, 701506, 701507, 701508, 701509, 701510, 701511, 701512, 701513, 701515, 701516, 701518, 701521, 701522, 701523, 701524, 701525, 701526, 701527, 701528, 701530, 701532, 701533, 701534, 701535, 701536, 701537, 701538, 701540, 701541, 701542, 701543, 701544, 701546, 701547, 701548, 701549, 701550, 701551, 701552, 701553, 701554, 701555, 701556, 701557, 701558, 702382, 702397, 702399, 702401, 702415, 702421, 702437, 702442, 702443, 702444, 702454, 702463, 702464, 702465, 702477, 702483, 702501, 702509, 702510, 702514, 702521, 702522, 702523, 702527, 702531, 702536, 702545, 702546, 702547, 702549, 702552, 702555, 702557, 702558, 702561, 702562, 702566, 702570, 702573, 702576, 702579, 702580, 702581, 702582, 702584, 702586, 702590, 702591, 702593, 702595, 702600, 702601, 702603, 702604, 702606, 702610, 702615, 702617, 702618, 702623, 702624, 702626, 702631, 702632, 702636, 702637, 702641, 702643, 702651, 702653, 702655, 702657, 702658, 702660, 702662, 702664, 702666, 702667, 702668, 702669, 702672, 702678, 702682, 702689, 702690, 702698, 702699, 702700, 702701, 702703, 702705, 702706, 702708, 702709, 702711, 702712, 702713, 702714, 702717, 702719, 702721, 702722, 702723, 702725, 702726, 702727, 702728, 702730, 702733, 702735, 702738, 702745, 702756, 702770, 702773, 702779, 702791, 702794, 702796, 702797, 702799, 702831, 702834, 702835, 702837, 702838, 702841, 702843, 702844, 702846, 702847, 702848, 702849, 702850, 702853, 702854, 702857, 702860, 702861, 702862, 702864, 702865, 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707602, 707604, 707605, 707606, 707607, 707608, 707609, 707610, 707613, 707615, 707617, 707619, 707620 b) U226, Serial Numbers: 100044, 100069, 100116, 700077, 700093, 700140, 700163, 700220, 700306, 700323, 700331, 100006, 100009, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100019, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100032, 100034, 100035, 100038, 100039, 100042, 100045, 100046, 100048, 100049, 100050, 100052, 100055, 100058, 100059, 100060, 100061, 100062, 100063, 100066, 100067, 100068, 100070, 100072, 100073, 100074, 100075, 100076, 100077, 100081, 100082, 100085, 100087, 100089, 100090, 100091, 100092, 100094, 100095, 100096, 100098, 100100, 100101, 100102, 100105, 100106, 100107, 100108, 100109, 100111, 100112, 100113, 100117, 100118, 100120, 100123, 100124, 100126, 100127, 100128, 100129, 100132, 100133, 100134, 100135, 100136, 700002, 700003, 700004, 700006, 700007, 700008, 700009, 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, 700043, 700044, 700045, 700048, 700050, 700051, 700052, 700053, 700054, 700056, 700057, 700058, 700059, 700060, 700061, 700063, 700065, 700066, 700067, 700068, 700071, 700072, 700074, 700075, 700076, 700079, 700081, 700082, 700083, 700084, 700087, 700088, 700089, 700090, 700091, 700092, 700094, 700095, 700096, 700098, 700099, 700101, 700102, 700103, 700106, 700107, 700108, 700109, 700110, 700111, 700113, 700114, 700115, 700116, 700118, 700120, 700121, 700122, 700123, 700124, 700125, 700126, 700132, 700135, 700137, 700139, 700141, 700142, 700143, 700145, 700146, 700147, 700149, 700151, 700153, 700154, 700155, 700156, 700159, 700164, 700167, 700168, 700169, 700170, 700171, 700172, 700183, 700184, 700186, 700187, 700191, 700192, 700193, 700194, 700198, 700199, 700201, 700205, 700207, 700208, 700209, 700210, 700211, 700212, 700213, 700214, 700215, 700216, 700218, 700219, 700222, 700225, 700226, 700227, 700229, 700230, 700231, 700232, 700236, 700237, 700239, 700240, 700241, 700245, 700246, 700247, 700249, 700265, 700309, 700310, 700311, 700312, 700313, 700314, 700316, 700318, 700319, 700321, 700325, 700326, 700327, 700328, 700329 c) U228, Serial Numbers: 702970, 726570, 100020, 100024, 100048, 100074, 100080, 100127, 100129, 100211, 100225, 100230, 100255, 100299, 100496, 101262, 101351, 101386, 101531, 101620, 101741, 101787, 101800, 101883, 101896, 101910, 101982, 102125, 102224, 102298, 700031, 700063, 700124, 700151, 700220, 700234, 700238, 700294, 700403, 700704, 700931, 701037, 701243, 701353, 701496, 701866, 701912, 701959, 702057, 702434, 702597, 702602, 702651, 702839, 703191, 703259, 703318, 703362, 703363, 703962, 703972, 703995, 704020, 704106, 704161, 704579, 704639, 704925, 704982, 705083, 705235, 705390, 705454, 705487, 705575, 705700, 705734, 705739, 705811, 706030, 706035, 706251, 706572, 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• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N Bldg 3; Saint Paul MN 55112-5700
• For Additional Information Contact: United States Technical Services; 800-227-3422
• Manufacturer Reason for Recall: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm began notifying its sales representatives on 06/02/2021 by email or hand delivery and followed with notifying the implanting/following physicians and centers on 06/03/2021 by letter. The letter explained the issue and provided recommendations for the physicians. Information is also posted on www.BostonScientific.com/advisory. Patient notification is done by the implanting/following physician.
• Quantity in Commerce: 5920 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NKE and Original Applicant = GUIDANT CORP.