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INTUA CRT-P, Model Numbers recallZ-2019-2021 · Boston Scientific Corporation · initiated Jun 3, 2021

Class I Open, Classified All recalls posted in July 2021

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

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

FDA root cause category: Device Design

What the company is doing

The firm issued an advisory communication on June 3, 2021 by letter to the implanting/following physicians and clinics regarding the potential device behavior. The notice included a letter to the patients to be disseminated to the patients implanted with the device at the discretion of the physician. BSC also made the patient letter available on their advisory page, found on our product performance website @ https://www.bostonscientific.com/en-US/pprc/product-advisories.html

Recall details

Recall number
Z-2019-2021
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Jun 3, 2021
Posted by the FDA
Jul 13, 2021
Recalling firm
Boston Scientific Corporation
Quantity
1707 units
Product code
NKE
FDA submissions
P030005
Distribution
Worldwide distribution.

Product description

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

Code information (models, lots, serial numbers)

Show the full code information (14k characters)

a) V272, Serial Numbers: 100002, 100014, 100017, 100021, 100028, 100037, 100048, 100052, 100053, 100054, 100065, 100067, 100068, 100075, 100077, 100080, 100092, 100093, 100096, 100097, 100098, 100099, 100101, 100104, 100106, 100107, 100108, 100114, 100116, 100118, 100119, 100120, 100124, 100127, 100136, 100152, 100153, 100155, 100159, 100161, 100162, 100165, 100168, 100170, 100171, 100173, 100175, 100176, 100179, 100194, 100195, 100199, 100201, 100202, 100203, 100205, 100206, 100211, 100212, 100216, 100218, 100219, 100221, 100224, 100226, 100227, 100228, 100230, 100232, 100233, 100237, 100238, 100240, 100241, 100242, 100245, 100247, 100249, 100250, 100253, 100256, 100257, 100258, 100261, 100266, 100270, 100272, 100276, 100277, 100280, 100281, 100287, 100289, 100290, 604977, 604982, 604984, 604986, 604987, 604988, 604991, 604992, 604998, 604999, 605002, 605003, 605004, 605005, 605006, 605007, 605009, 605010, 605011, 605013, 605014, 605015, 605017, 605020, 605021, 605022, 605023, 605025, 605026, 605027, 605028, 605029, 605035, 605036, 605037, 605039, 605041, 605047, 605049, 605051, 605052, 605055, 605057, 605058, 605061, 605062, 605063, 605064, 605065, 605070, 605073, 605075, 605076, 605079, 605080, 605082, 605085, 605087, 605088, 605090, 605096, 605098, 605099, 605100, 605103, 605108, 605112, 605115, 605117, 605118, 605120, 605124, 605127, 605128, 605129, 605133, 605135, 605136, 605137, 605140, 605141, 605147, 605149, 605150, 605151, 605152, 605153, 605154, 605155, 605158, 605159, 605161, 605162, 605163, 605164, 605166, 605168, 605170, 605172, 605173, 605174, 605175,   b) V273, Serial Numbers: 100001, 100002, 100006, 100007, 100013, 100014, 100015, 100017, 100019, 100030, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100042, 100044, 100045, 100046, 100047, 100048, 100049, 100054, 100056, 100057, 100058, 100060, 100062, 100066, 100067, 100069, 100071, 100072, 100076, 100083, 100084, 100086, 100087, 100088, 100089, 100090, 100091, 100093, 100096, 100097, 100100, 100101, 100103, 100104, 100107, 100116, 100117, 100118, 100119, 100120, 100121, 100123, 100126, 100128, 100131, 100134, 100135, 100138, 100139, 100140, 100141, 100142, 100143, 100146, 100148, 100152, 100154, 100155, 100156, 100157, 100159, 100166, 100168, 100174, 100175, 100180, 100182, 100184, 100185, 100187, 100192, 100197, 100199, 100201, 100202, 100206, 100209, 100211, 100212, 100213, 100219, 100227, 100229, 100230, 100232, 100234, 100235, 100237, 100241, 100242, 100244, 100245, 100249, 100250, 100251, 100253, 100254, 100255, 100259, 100263, 100265, 100266, 100270, 100275, 100277, 100284, 100285, 100286, 100288, 100289, 100290, 100294, 100296, 100298, 100299, 100300, 100301, 100302, 100303, 100304, 100306, 100307, 100309, 100311, 100317, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100328, 100333, 100334, 100335, 100336, 100339, 100340, 100341, 100344, 100345, 100347, 100348, 100349, 100350, 100352, 100353, 100355, 100357, 100358, 100361, 100363, 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100608.100611, 100613, 100615, 100617, 100618, 100622, 100627, 100629, 100630, 100632, 100637, 100638, 100641, 100643, 100644, 100645, 100646, 100647, 100653, 100654, 100658, 100659, 100660, 100661, 100664, 100665, 100666, 100667, 100668, 100669, 100670, 100671, 100674, 100675, 100676, 100679, 100680, 100682, 100683, 100684, 100685, 100686, 100687, 100688, 100689, 100690, 100692, 100693, 100694, 100695, 100697, 100700, 100701, 100702, 100706, 100708, 100709, 100712, 100714, 100715, 100716, 100717, 100719, 100721, 100722, 100723, 100725, 100726, 100727, 100730, 100731, 100735, 100736, 100740, 100742, 100744, 100745, 100747, 100748, 100751, 100753, 100755, 100757, 100758, 100759, 100761, 100763, 100764, 100765, 100766, 100767, 100769, 100774, 100776, 100779, 100781, 100782, 100783, 100784, 100787, 100788, 100789, 100791, 100795, 100797, 100798, 100799, 100805, 100806, 100807, 100808, 100810, 100812, 100814, 100815, 100816, 100817, 100818, 100820, 100821, 100822, 100824, 100825, 100826, 100827, 100828, 100830, 100831, 100833, 100834, 100835, 100836, 100837, 100838, 100839, 100841, 100842, 100845, 100846, 100847, 100852, 100853, 100854, 100856, 100857, 100858, 100859, 100860, 100861, 100863, 100868, 100869, 100870, 100871, 100872, 100873, 100874, 100876, 100879, 100885, 100886, 100887, 100888, 100889, 100890, 100893, 100894, 100897, 100898, 100900, 100901, 100903, 100904, 100905, 100906, 100907, 100908, 100909, 100913, 100914, 100916, 100917, 100919, 100920, 100921, 100922, 100925, 100926, 100927, 100929, 100931, 100932, 100937, 100939, 100941, 100942, 100943, 100945, 100946, 100947, 100949, 100951, 100952, 100953, 100955, 100956, 100957, 100958, 100959, 100963, 100964, 100965, 100966, 100968, 100969, 100970, 100971, 100972, 100973, 100974, 100975, 100978, 100980, 100981, 100982, 100983, 100984, 100985, 100986, 100987, 100988, 100989, 100991, 100994, 100997, 100999, 101000, 101006, 101007, 101008, 101009, 101011, 101012, 101013, 101015, 101017, 101020, 101022, 101023, 101026, 101033, 101035, 101036, 101037, 101038, 101039, 101040, 101042, 101044, 101045, 101051, 101054, 101055, 101057, 101059, 101061, 101062, 101063, 101066, 101068, 101069, 101072, 101075, 101076, 101078, 101084, 101085, 101086, 101092, 101093, 101095, 101097, 101099, 101100, 101101, 101102, 101103, 101104, 101105, 101106, 101107, 101108, 101111, 101113, 101114, 101115, 101116, 101117, 101118, 101122, 101123, 101124, 101128, 101130, 101132, 101133, 101134, 101135, 101136, 101137, 101142, 101144, 101147, 101149, 101152, 101154, 101155, 101156, 101157, 101158, 101159, 101160, 101162, 101166, 101168, 101169, 101173, 101174, 101176, 101179, 101180, 101182, 101184, 101186, 101187, 101188, 101193, 101194, 101195, 101197, 101199, 101201, 101204, 101206, 101207, 101208, 101212, 101213, 101216, 101217, 101218, 101219, 101221, 101223, 101224, 101225, 101226, 101231, 101233, 101234, 101238, 101239, 101240, 101242, 101243, 101244, 101245, 101247, 101248, 101249, 101252, 101254, 101255, 101257, 101258, 101259, 101260, 101261, 101262, 101263, 101265, 101271, 101273, 101274, 101275, 101277, 101278, 101279, 101280, 101282, 101286, 101287, 101288, 101290, 101292, 101293, 101295, 101297, 101300, 101303, 101304, 101306, 101311, 101312, 101313, 101314, 101315, 101318, 101319, 101323, 101324, 101325, 101327, 101329, 101330, 101332, 101333, 101334, 101337, 101338, 101340, 101341, 101342, 101343, 101345, 101346, 101347, 101350, 101351, 101353, 101354, 101355, 101356, 101357, 101359, 101360, 101362, 101364, 101369, 101370, 101372, 101373, 101374, 101375, 101377, 101379, 101380, 101383, 101384, 101385, 101386, 101387, 101389, 101390, 101391, 101392, 101393, 101397, 101400, 101401, 101402, 101403, 101404, 101407, 101408, 101409, 101410, 101411, 101412, 101413, 101414, 101415, 101417, 101418, 101419, 101420, 117819, 117820, 117822, 117824, 117825, 117826, 117831, 117833, 117836, 117838, 117839, 117842, 117844, 117846, 117847, 117848, 117851, 117852, 117854, 117855, 117856, 117857, 117860, 117863.117865, 117866, 117867, 117868, 117869, 117871, 117872, 117873, 117876, 117877, 117881, 117882, 117883, 117884, 117885, 117886, 117887, 117888, 117889, 117890, 117891, 117892, 117894, 117895, 117896, 117897, 117900, 117901, 117902, 117903, 117904, 117905, 117906, 117907, 117908, 117910, 117911, 117912, 117913, 117916, 117918, 117919, 117920, 117921, 117922, 117923, 117924, 117925, 117926, 117927, 117929, 117930, 117932, 117935, 117936, 117937, 117938, 117944, 117947, 117948, 117951, 117952, 117953, 117954, 117956, 117959, 117960, 117961, 117962, 117964, 117965, 117966, 117967, 117969, 117971, 117972, 117974, 117975, 117976, 117977, 117978, 117979, 117980, 117981, 117983, 117984, 117986, 117989, 117991, 117992, 117993, 117994, 117995, 117996, 117997, 117998, 118001, 118002, 118005, 118006, 118007, 118008, 118009, 118010, 118013, 118015, 118016, 118019, 118021, 118022, 118023, 118024, 118026, 118027, 118028, 118029, 118031, 118032, 118033, 118035, 118036, 118037, 118038, 118040, 118041, 118046, 118047, 118049, 118051, 118052, 118054, 118055, 118056, 118057, 118058, 118059, 118062, 118063, 118066, 118068, 118069, 118070, 118072, 118074, 118075, 118076, 118077, 118078, 118081, 118084, 118085, 118087, 118088, 118091, 118094, 118095, 118096, 118098, 118101, 118104, 118105, 118106, 118108, 118109, 118110, 118111, 118113, 118114, 118115, 118116, 118118, 118119, 118120, 118121, 118122, 118123, 118124, 118125, 118127, 118129, 118130, 118131, 118133, 118134, 118135, 118136, 118138, 118141, 118143, 118145, 118147, 118148, 118149, 118150, 118152, 118153, 118154, 118155, 118156, 118158, 118159, 118163, 118164, 118167, 118168, 118169, 118170, 118173, 118174, 118175, 118176, 118177, 118178, 118179, 118181, 118182, 118185, 118186, 118187, 118188, 118189, 118190, 118191, 118192, 118193, 118194, 118195, 118197, 118198, 118199, 118200, 118201, 118203, 118206, 118208, 118211, 118212, 118213, 118217, 118218, 118219, 118223, 118224, 118225, 118226, 118227, 118228, 118229, 118231, 118232, 118233, 118234, 118235, 118236, 118237, 118238, 118240, 118243, 118245, 118246, 118248, 118249, 118250, 118253, 118254, 118255, 118256, 118257, 118259, 118261, 118263, 118265, 118267, 118269, 118272, 118273, 118274, 118275, 118277, 118278, 118281, 118282, 118286, 118291, 118292, 118293, 118294, 118295, 118297, 118301, 118303, 118307, 118308, 118309, 118310, 118311, 118312, 118313, 118314, 118318, 118319, 118321, 118322, 118324, 118325, 118328, 118330, 118332, 118333, 118334, 118335, 118339, 118340, 118341, 118342, 118344, 118345, 118346, 118347, 118348, 118349, 118350, 118351, 118353, 118354, 118355, 118357, 118358, 118362, 118423, 118425, 118426, 118428, 118429, 118430, 118431, 118433, 118434, 118435, 118436, 118437, 118438, 118440, 118441, 118443, 118446, 118449, 118450, 118451, 118452, 118453, 118454, 118455, 118457, 118458, 118460, 118461, 118463, 118464, 118466, 118467, 118468, 118469, 118471, 118472, 118474, 118477, 118478, 118479, 118481, 118482, 118483, 118484, 118486, 118487, 118489, 118490, 118491, 118492, 118493, 118495, 118496, 118497, 118498, 118500, 118501, 118503, 118505, 118506, 118507, 118509, 118510, 118511, 118512, 118513, 118518, 118520, 118524, 118525, 118526, 118527, 118529, 118530, 118532, 118534, 118535, 118536, 118537, 118538, 118539, 118541, 118543, 118545, 118546, 118550, 118551, 118552, 118553, 118554, 118555, 118559, 118560, 118563, 118564, 118565, 118567, 118568, 118569, 118570, 118572, 118575, 118577, 118578, 118587, 118588, 118590, 118592, 118595, 118597, 118599, 118600, 118601, 118602, 118603, 118604, 118605, 118606, 118607, 118608, 118609, 118610, 118611, 118614, 118618, 118619, 118620, 118621, 118623, 118627, 118630, 118631, 118633, 118635, 118636, 118637, 118639, 118641, 118642, 118643, 118644, 118647, 118649, 118651, 118652, 118654, 118655, 118657, 118658, 118659, 118661, 118662, 118663, 118666, 118668, 118669, 118670, 118672, 118673, 118674, 118675, 118677, 118678, 118679, 118680, 118682, 118683, 118684, 118686, 118687, 118688.118690, 118691, 118692, 118693, 118694, 118695, 118696, 118700, 118701, 118702, 118703, 118705, 118706, 118707, 118708, 118709, 118711, 118713, 118714, 118717, 118718, 118719, 118721, 118722, 118724, 118725, 118727, 118728, 118729, 118731, 118732, 118733, 118734, 118735, 118736, 118737, 118739, 118741, 118742, 118743, 118745, 118751, 118755, 118756, 118758, 118759, 118760, 118761, 118763, 118765, 118766, 118767, 118768, 118769, 118771, 118772, 118773, 118774, 118775, 118776, 118777, 118778, 118779, 118781, 118782, 118785, 118786, 118788, 118789, 118790, 118792, 118794, 118795, 118797, 118798, 118799, 118800, 118804, 118807, 118810, 118812, 118813, 118815, 118816, 118820, 118821, 118822, 118823, 118824, 118825, 118826, 118827, 118828, 118829, 118830, 118835, 118836, 118837, 118838, 118839, 118840, 118842, 118846, 118848, 118849, 118850, 118854, 118856, 118859, 118860, 118861, 118863, 118864, 118865, 118867, 118869, 118870, 118871, 118873, 118874, 118875, 118876, 118877, 118879, 118880, 118882, 118883, 118884, 118885, 118886, 118887, 118888, 118891, 118894, 118895, 118896, 118897, 118898, 118899, 118900, 118901, 118902, 118903, 118907, 118908, 118909, 118910, 118912, 118914, 118918, 118919, 118920, 118921, 118922, 118923, 118924, 118928, 118929, 118933, 118935, 118936, 118937, 118938, 118939, 118942, 118944, 118945, 118946, 118947, 118949, 118950, 118951, 118954, 118955, 118957, 118958, 118959, 118961, 118962, 118967, 118968, 118972, 118974, 118977, 118978, 118979, 118980, 118981, 118982, 117901, 118894  c) W273, Serial Numbers: 100003, 100005, 100009, 100024, 100030, 100037, 100091, 100092, 100093, 100100, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100126, 100021, 100118, 100121, 100127

Other devices under the same FDA submission

9 devices cleared under P030005 — the recall does not name any of them by identifier. 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 88107).

Sources and updates

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