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

Recall number

Z-2019-2021

Recalling firm

Boston Scientific Corporation

Product

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

Status

Open, Classified

Initiated

2021-06-03

Posted

2021-07-13

Terminated

not on file

Reason

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

Root cause

Device Design

Action

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

Quantity

1707 units

Distribution

Worldwide distribution.

Lot, serial or model codes

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, 100366, 100367, 100369, 100370, 100375, 100376, 100377, 100378, 100379, 100380, 100381, 100382, 100383, 100385, 100386, 100388, 100390, 100394, 100396, 100397, 100398, 100402, 100404, 100405, 100407, 100408, 100414, 100417, 100419, 100426, 100428, 100429, 100430, 100431, 100432, 100434, 100435, 100436, 100437, 100439, 100442, 100443, 100444, 100445, 100446, 100452, 100455, 100457, 100459, 100460, 100461, 100464, 100465, 100466, 100469, 100476, 100479, 100481, 100484, 100486, 100487, 100488, 100491, 100494, 100496, 100500, 100503, 100504, 100505, 100510, 100511, 100513, 100516, 100517, 100518, 100519, 100520, 100523, 100526, 100528, 100531, 100533, 100535, 100536, 100541, 100542, 100543, 100544, 100547, 100549, 100551, 100555, 100556, 100557, 100559, 100560, 100561, 100562, 100563, 100564, 100566, 100567, 100572, 100573, 100574, 100575, 100578, 100579, 100580, 100583, 100584, 100588, 100589, 100591, 100592, 100593, 100594, 100595, 100596, 100597, 100603, 100604, 100605, 100607, 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

510(k) numbers

not on file

PMA numbers

["P030005"]

Product code

NKE

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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