Class 2 Device Recall VALITUDE CRTP

• Date Initiated by Firm: June 03, 2021
• Date Posted: July 02, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2002-2021
• Recall Event ID: 88087
• PMA Number: P030005
• Product Classification: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
• Product: VALITUDE CRT-P pacemaker, Models:; a) U125; b) U128
• Code Information: a) U125, Serial Numbers: 100009, 100057, 100074, 100257, 100521, 700037, 700061, 700068, 700074, 700172, 700179, 700190, 700253, 702556, 702777, 702999, 703683, 703806, 704048, 707332, 707470, 707508, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100010, 100011, 100013, 100015, 100020, 100024, 100026, 100028, 100029, 100033, 100050, 100054, 100058, 100062, 100063, 100066, 100067, 100068, 100069, 100071, 100076, 100079, 100081, 100084, 100085, 100086, 100091, 100102, 100106, 100110, 100133, 100136, 100146, 100148, 100149, 100150, 100157, 100159, 100163, 100164, 100165, 100171, 100175, 100188, 100192, 100199, 100200, 100201, 100202, 100203, 100205, 100208, 100209, 100210, 100211, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100222, 100224, 100226, 100228, 100231, 100234, 100235, 100237, 100244, 100245, 100248, 100249, 100250, 100251, 100253, 100256, 100265, 100267, 100268, 100272, 100274, 100275, 100277, 100279, 100283, 100284, 100290, 100308, 100317, 100391, 100416, 100417, 100426, 100450, 100451, 100507, 100509, 100511, 100512, 100520, 100556, 100606, 100621, 100662, 100663, 100665, 100668, 100709, 100739, 100741, 100796, 100797, 100815, 100816, 100820, 100831, 100836, 100838, 100839, 100848, 100855, 100857, 100859, 100862, 100863, 100867, 100872, 100882, 100885, 100898, 100899, 100903, 100911, 100914, 100918, 100920, 100927, 100936, 100937, 700001, 700004, 700005, 700008, 700009, 700010, 700011, 700012, 700014, 700017, 700019, 700020, 700022, 700023, 700026, 700028, 700029, 700031, 700034, 700036, 700038, 700041, 700049, 700051, 700053, 700054, 700055, 700057, 700058, 700062, 700065, 700069, 700070, 700076, 700079, 700086, 700087, 700090, 700091, 700093, 700095, 700097, 700098, 700101, 700107, 700111, 700112, 700113, 700114, 700119, 700123, 700127, 700129, 700131, 700133, 700135, 700136, 700137, 700139, 700144, 700147, 700154, 700158, 700161, 700162, 700163, 700164, 700166, 700167, 700168, 700169, 700171, 700173, 700174, 700175, 700176, 700177, 700178, 700181, 700182, 700183, 700184, 700185, 700187, 700192, 700193, 700194, 700195, 700196, 700199, 700204, 700208, 700219, 700223, 700224, 700228, 700229, 700230, 700231, 700232, 700233, 700236, 700237, 700238, 700240, 700241, 700242, 700244, 700247, 700248, 700251, 700254, 700255, 700257, 700258, 700259, 700260, 700263, 700265, 700266, 700267, 700269, 700275, 700276, 700282, 700283, 700287, 700289, 700290, 700518, 700521, 700589, 700675, 700700, 700702, 700746, 700747, 700759, 700771, 700786, 700806, 700823, 700848, 700850, 700859, 700875, 700879, 701243, 701258, 701276, 701342, 701352, 701380, 701388, 701394, 701442, 701517, 702420, 702440, 702447, 702451, 702452, 702460, 702479, 702480, 702487, 702490, 702491, 702492, 702493, 702496, 702497, 702499, 702500, 702503, 702504, 702519, 702532, 702533, 702535, 702538, 702550, 702551, 702554, 702563, 702571, 702572, 702575, 702577, 702583, 702585, 702589, 702598, 702599, 702605, 702608, 702611, 702613, 702614, 702625, 702633, 702642, 702647, 702670, 702675, 702677, 702681, 702683, 702684, 702697, 702739, 702750, 702761, 702766, 702767, 702798, 702833, 702856, 702866, 702872, 702879, 702964, 702966, 702970, 702974, 702978, 702982, 702984, 702987, 702993, 703001, 703008, 703009, 703010, 703034, 703054, 703113, 703140, 703260, 703261, 703274, 703680, 703684, 703706, 703718, 703728, 703736, 703742, 703748, 703753, 703782, 703787, 703791, 703792, 703793, 703797, 703798, 703799, 703800, 703801, 703802, 703803, 703805, 703807, 703811, 703813, 703818, 703819, 703820, 703821, 703824, 703828, 703829, 703832, 703833, 703834, 703836, 703837, 703839, 703843, 703851, 703853, 703856, 703857, 703859, 703870, 703877, 703887, 703947, 703962, 703963, 704003, 704030, 704032, 704039, 704043, 704060, 704088, 705122, 705124, 705126, 705128, 705130, 705134, 705137, 707314, 707315, 707317, 707318, 707319, 707331, 707343, 707345, 707350, 707368, 707370, 707371, 707372, 707410, 707412, 707413, 707421, 707422, 707442, 707443, 707446, 707447, 707450, 707455, 707458, 707460, 707462, 707468, 707471, 707472, 707478, 707484, 707496, 707518, 707527, 707529, 707536, 707556, 707557, 707565, 707573, 707575, 707582, 707601, 707603, 707612, 707614, 707627 b) U128, Serial Numbers: 100184, 100187, 100217, 100222, 100236, 100240, 100247, 100251, 100253, 100256, 100260, 100262, 100274, 100275, 100277, 100289, 100308, 100317, 100328, 100330, 100331, 100338, 100339, 100346, 100350, 100351, 100355, 100357, 100359, 100361, 100363, 100364, 100369, 100371, 100372, 100373, 100376, 100377, 100378, 100379, 100380, 100381, 100383, 100386, 100389, 100390, 100391, 100392, 100393, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100405, 100409, 100410, 100411, 100413, 100414, 100417, 100419, 100420, 100433, 100435, 100437, 100438, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100454, 100456, 100458, 100459, 100461, 100463, 100466, 100468, 100471, 100473, 100474, 100475, 100476, 100478, 100479, 100480, 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100791, 100792, 100793, 100794, 100795, 100798, 100799, 100801, 100804, 100805, 100806, 100807, 100808, 100817, 100839, 100840, 100841, 100842, 100881, 100882, 100889, 100907, 100939, 100941, 100971, 100972, 100974, 100975, 100977, 100979, 100980, 100982, 100983, 100984, 100985, 100987, 100988, 100989, 100990, 100991, 100992, 100993, 100994, 100995, 100998, 101000, 101001, 101002, 101003, 101004, 101005, 101007, 101009, 101011, 101012, 101014, 101018, 101021, 101022, 101024, 101026, 101027, 101038, 101039, 101041, 101044, 101045, 101048, 101052, 101054, 101056, 101057, 101058, 101066, 101069, 101072, 101089, 101102, 101103, 101104, 101107, 101109, 101110, 101115, 101116, 101117, 101118, 101120, 101121, 101122, 101125, 101127, 101128, 101129, 101130, 101131, 101133, 101134, 101135, 101136, 101137, 101138, 101139, 101140, 101142, 101143, 101146, 101147, 101148, 101159, 101169, 101171, 101174, 101176, 101177, 101180, 101181, 101184, 101186, 101199, 101206, 101233, 101242, 101244, 101250, 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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: 6377 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.