—#187903

Product

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

FDA product code: NKE — Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P030005
Affected lot / code info: 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

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

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Bldg 3, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2021-06-03
Posted by FDA: 2021-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187903. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.