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U.S. Department of Health and Human Services

Class 1 Device Recall INLIVEN CRTP

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 Class 1 Device Recall INLIVEN CRTPsee related information
Date Initiated by FirmJune 03, 2021
Date PostedJuly 13, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2020-2021
Recall Event ID 88107
PMA NumberP030005 
Product Classification Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
ProductINLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Code Information a) V284, Serial Numbers: 100002, 100000, 100003, 100005, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100022, 100023, 100027, 100029, 234350, 234352 b) V285, Serial Numbers: 246521, 100000, 100002, 100007, 100018, 100026, 100036, 100059, 100065, 100087, 100097, 100101, 100111, 100117, 100126, 100127, 100136, 100139, 100141, 100154, 100156, 100158, 100159, 100161, 100162, 100163, 246441, 246442, 246446, 246447, 246449, 246451, 246453, 246458, 246459, 246463, 246469, 246470, 246471, 246472, 246473, 246474, 246475, 246477, 246481, 246483, 246484, 246485, 246486, 246495, 246496, 246497, 246499, 246500, 246501, 246503, 246504, 246505, 246506, 246508, 246509, 246512, 246519, 246520, 246521, 246527, 246529, 246532, 246534, 246542, 246546, 246549, 246554, 246577, 246586, 246590, 246591, 246592, 246593, 246596, 246598, 246610, 246611, 246613, 246619, 246623, 246627, 246628, 246630, 246634, 246636, 246637, 246645, 246646, 246647, 246650, 246654, 246656, 246658, 246664, 246665, 246667, 246672, 246673, 246677, 246679, 246681, 246683, 246686, 246688, 246690, 246693, 246694, 246697, 246704, 246709, 246710, 246713, 246714, 246721, 246730, 246748, 246752, 246756, 246759, 246762, 246764, 246765, 246766, 246769, 100003, 100004, 100005, 100008, 100009, 100010, 100012, 100013, 100015, 100016, 100017, 100019, 100020, 100021, 100023, 100025, 100027, 100028, 100029, 100030, 100031, 100032, 100033, 100035, 100037, 100038, 100039, 100040, 100042, 100043, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100060, 100061, 100062, 100066, 100067, 100068, 100069, 100071, 100072, 100074, 100075, 100076, 100077, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100091, 100093, 100095, 100098, 100100, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100112, 100114, 100115, 100116, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100137, 100138, 100140, 100142, 100143, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100155, 100157, 100160, 100164, 246436, 246437, 246438, 246439, 246440, 246443, 246444, 246445, 246448, 246450, 246452, 246454, 246455, 246456, 246460, 246461, 246462, 246464, 246465, 246466, 246467, 246476, 246478, 246480, 246482, 246487, 246488, 246489, 246490, 246491, 246492, 246493, 246494, 246498, 246502, 246507, 246510, 246511, 246514, 246515, 246516, 246518, 246522, 246524, 246525, 246526, 246528, 246530, 246535, 246541, 246543, 246544, 246545, 246548, 246550, 246551, 246552, 246555, 246556, 246558, 246559, 246560, 246561, 246564, 246566, 246567, 246568, 246569, 246570, 246571, 246572, 246573, 246574, 246575, 246576, 246578, 246579, 246580, 246581, 246582, 246583, 246584, 246585, 246587, 246588, 246589, 246594, 246595, 246597, 246602, 246603, 246604, 246606, 246607, 246608, 246609, 246614, 246615, 246616, 246617, 246618, 246620, 246621, 246622, 246624, 246625, 246626, 246629, 246631, 246633, 246635, 246640, 246641, 246642, 246643, 246644, 246649, 246651, 246652, 246653, 246655, 246657, 246659, 246660, 246661, 246662, 246663, 246668, 246670, 246675, 246676, 246678, 246680, 246682, 246684, 246685, 246687, 246691, 246692, 246695, 246696, 246698, 246699, 246700, 246701, 246702, 246703, 246705, 246706, 246708, 246711, 246712, 246715, 246717, 246718, 246719, 246720, 246723, 246724, 246725, 246726, 246728, 246729, 246731, 246732, 246733, 246734, 246736, 246738, 246739, 246740, 246741, 246742, 246743, 246744, 246745, 246746, 246749, 246750, 246751, 246755, 246757, 246758, 246767 c) W274, Serial Numbers: 111154, 111189, 111247, 111112, 111113, 111114, 111115, 111118, 111119, 111120, 111121, 111122, 111124, 111125, 111127, 111128, 111131, 111133, 111134, 111136, 111138, 111139, 111140, 111142, 111143, 111144, 111145, 111147, 111148, 111149, 111150, 111151, 111152, 111155, 111158, 111159, 111163, 111164, 111165, 111166, 111167, 111168, 111169, 111171, 111173, 111174, 111175, 111176, 111177, 111180, 111181, 111184, 111185, 111186, 111187, 111188, 111191, 111192, 111193, 111195, 111196, 111197, 111198, 111199, 111203, 111204, 111205, 111206, 111208, 111209, 111211, 111213, 111214, 111215, 111216, 111220, 111221, 111222, 111225, 111226, 111227, 111230, 111231, 111232, 111233, 111234, 111236, 111237, 111241, 111242, 111244, 111249, 111250, 111251, 111256, 111257, 111261, 111262, 111264, 111267, 111268, 111270, 111271, 111272, 111275, 111276, 111278, 111279, 111281, 111282, 111284, 111285, 111288, 111289, 111293, 111294, 111299, 111300, 111301, 111302, 111304, 111305, 111307, 111312, 111314, 111316, 111317, 111323, 111327, 111328, 111332, 111334, 111336, 111337, 111338, 111341, 111343, 111345, 111346, 111347, 111348, 111349, 111350, 111351, 111356, 111357, 111358, 111359, 111360, 111362, 111363, 111365, 111366, 111367, 111368, 111369, 111370, 111372, 111373, 111374, 111378, 111380, 111381, 111382, 111385, 111387, 111388, 111389, 111390, 111391, 300711, 300713, 300714, 300716, 300717, 300718, 300719, 300731 d) W275, Serial Numbers: 111149, 111152, 111164, 111166, 111178, 111189, 111190, 111207, 111217, 111218, 111230, 111256, 111287, 111310, 111321, 111363, 111373, 111379, 111394, 111397, 111405, 111407, 111417, 111423, 111441, 111466, 111472, 111484, 111486, 111489, 111516, 111519, 111524, 111536, 111545, 111559, 111566, 111593, 111609, 111613, 111692, 111703, 111709, 111765, 111773, 111820, 111826, 111842, 111883, 111959, 111974, 111991, 112097, 112159, 112165, 112194, 112226, 112284, 112367, 112459, 112469, 112473, 112497, 112500, 112574, 112578, 112642, 112644, 112685, 112691, 112710, 112711, 112724, 112958, 112982, 112994, 112999, 113042, 113059, 113061, 113126, 113137, 113144, 113175, 113192, 113295, 113297, 113302, 113322, 113377, 113416, 113444, 113550, 300827, 300843, 300955, 301017, 301059, 301132, 301155, 301185, 301256, 301259, 301261, 301263, 301264, 301265, 301267, 301270, 301271, 301272, 301273, 301275, 301277, 301281, 301282, 301284, 301289, 301293, 301296, 301300, 301302, 301305, 301306, 301363, 301364, 301371, 301377, 301398, 301478, 301480, 301491, 301494, 111119, 111120, 111121, 111122, 111123, 111124, 111125, 111127, 111128, 111129, 111130, 111131, 111132, 111133, 111135, 111136, 111137, 111138, 111139, 111140, 111141, 111142, 111143, 111144, 111145, 111146, 111147, 111148, 111150, 111151, 111153, 111154, 111155, 111156, 111157, 111158, 111159, 111160, 111161, 111162, 111163, 111165, 111167, 111168, 111169, 111170, 111171, 111173, 111174, 111175, 111176, 111177, 111179, 111180, 111181, 111182, 111183, 111184, 111186, 111187, 111188, 111191, 111193, 111194, 111195, 111196, 111197, 111198, 111199, 111200, 111201, 111202, 111203, 111205, 111206, 111208, 111209, 111210, 111211, 111212, 111214, 111215, 111216, 111219, 111220, 111221, 111222, 111223, 111224, 111225, 111226, 111227, 111228, 111229, 111231, 111233, 111234, 111235, 111236, 111237, 111238, 111239, 111240, 111241, 111242, 111243, 111244, 111245, 111246, 111247, 111248, 111249, 111250, 111251, 111252, 111253, 111255, 111257, 111258, 111260, 111263, 111265, 111267, 111268, 111269, 111270, 111271, 111272, 111273, 111274, 111275, 111276, 111277, 111279, 111281, 111283, 111284, 111285, 111286, 111289, 111291, 111293, 111294, 111296, 111297, 111298, 111300, 111301, 111303, 111304, 111307, 111308, 111309, 111311, 111312, 111313, 111315, 111316, 111317, 111318, 111319, 111320, 111322, 111323, 111325, 111326, 111327, 111328, 111329, 111331, 111332, 111333, 111334, 111335, 111336, 111337, 111338, 111339, 111342, 111343, 111344, 111345, 111346, 111348, 111349, 111350, 111351, 111352, 111353, 111354, 111355, 111356, 111357, 111359, 111360, 111361, 111362, 111364, 111366, 111367, 111368, 111369, 111370, 111371, 111372, 111376, 111378, 111380, 111381, 111382, 111383, 111384, 111386, 111387, 111388, 111389, 111390, 111391, 111392, 111396, 111398, 111399, 111400, 111401, 111403, 111404, 111406, 111408, 111409, 111410, 111411, 111412, 111414, 111415, 111416, 111419, 111420, 111421, 111422, 111424, 111425, 111427, 111428, 111429, 111430, 111431, 111432, 111433, 111434, 111435, 111436, 111437, 111439, 111440, 111442, 111443, 111444, 111445, 111446, 111447, 111448, 111449, 111450, 111451, 111452, 111453, 111454, 111455, 111456, 111457, 111459, 111460, 111461, 111462, 111463, 111464, 111465, 111467, 111468, 111469, 111471, 111474, 111475, 111476, 111477, 111478, 111479, 111480, 111481, 111483, 111485, 111488, 111490, 111491, 111492, 111493, 111495, 111496, 111498, 111499, 111500, 111501, 111503, 111504, 111505, 111506, 111507, 111508, 111509, 111510, 111511, 111512, 111513, 111514, 111515, 111517, 111518, 111520, 111521, 111522, 111523, 111525, 111528, 111529, 111530, 111532, 111533, 111534, 111535, 111539, 111541, 111542, 111543, 111544, 111546, 111547, 111548, 111549, 111550, 111551, 111552, 111553, 111554, 111555, 111556, 111557, 111558, 111560, 111561, 111562, 111564, 111565, 111567, 111568, 111569, 111570, 111571, 111572, 111574, 111576, 111578, 111579, 111580, 111581, 111582, 111583, 111585, 111586, 111587, 111588, 111590, 111591, 111594, 111595, 111596, 111597, 111598, 111599, 111600, 111601, 111602, 111604, 111605, 111606, 111607, 111608, 111610, 111612, 111614, 111618, 111619, 111620, 111621, 111622, 111623, 111624, 111626, 111627, 111628, 111629, 111630, 111631, 111632, 111633, 111635, 111636, 111637, 111638, 111639, 111640, 111641, 111643, 111644, 111645, 111647, 111648, 111649, 111652, 111653, 111654, 111655, 111656, 111658, 111659, 111660, 111661, 111662, 111663, 111664, 111665, 111666, 111668, 111669, 111670, 111671, 111672, 111673, 111675, 111676, 111677, 111678, 111679, 111680, 111682, 111684, 111685, 111686, 111687, 111688, 111689, 111690, 111693, 111695, 111696, 111697, 111699, 111700, 111701, 111704, 111705, 111706, 111707, 111710, 111711, 111712, 111713, 111714, 111715, 111716, 111717, 111718, 111719, 111720, 111721, 111722, 111723, 111724, 111725, 111726, 111727, 111729, 111730, 111731, 111732, 111733, 111734, 111735, 111736, 111737, 111738, 111739, 111740, 111741, 111742, 111743, 111744, 111745, 111746, 111747, 111748, 111749, 111750, 111751, 111752, 111753, 111754, 111755, 111756, 111757, 111758, 111759, 111760, 111761, 111762, 111763, 111764, 111766, 111767, 111768, 111770, 111771, 111772, 111774, 111775, 111776, 111777, 111778, 111779, 111780, 111781, 111782, 111783, 111784, 111785, 111787, 111788, 111789, 111790, 111792, 111793, 111794, 111795, 111796, 111798, 111799, 111800, 111801, 111802, 111803, 111804, 111805, 111806, 111808, 111809, 111810, 111811, 111812, 111813, 111814, 111815, 111816, 111817, 111818, 111819, 111821, 111822, 111823, 111824, 111825, 111827, 111828, 111829, 111830, 111831, 111833, 111834, 111835, 111836, 111837, 111838, 111839, 111840, 111841, 111843, 111845, 111846, 111847, 111849, 111850, 111851, 111852, 111853, 111855, 111856, 111857, 111859, 111860, 111861, 111862, 111863, 111864, 111866, 111867, 111868, 111869, 111870, 111871, 111872, 111873, 111874, 111875, 111876, 111877, 111878, 111879, 111880, 111881, 111882, 111884, 111885, 111886, 111888, 111889, 111890, 111891, 111893, 111894, 111895, 111896, 111897, 111898, 111899, 111900, 111902, 111903, 111904, 111905, 111906, 111907, 111908, 111909, 111910, 111911, 111912, 111913, 111914, 111915, 111916, 111917, 111918, 111920, 111921, 111922, 111923, 111924, 111925, 111926, 111928, 111930, 111931, 111932, 111933, 111934, 111935, 111936, 111937, 111938, 111939, 111940, 111941, 111942, 111943, 111944, 111945, 111946, 111948, 111949, 111951, 111952, 111953, 111954, 111955, 111956, 111957, 111958, 111960, 111961, 111963, 111964, 111965, 111966, 111967, 111968, 111969, 111970, 111971, 111972, 111973, 111975, 111976, 111977, 111978, 111979, 111980, 111981, 111982, 111983, 111984, 111985, 111986, 111987, 111989, 111990, 111992, 111993, 111994, 111995, 111996, 111997, 111999, 112000, 112001, 112002, 112003, 112004, 112005, 112006, 112008, 112009, 112010, 112011, 112012, 112013, 112014, 112015, 112016, 112017, 112018, 112019, 112020, 112021, 112022, 112023, 112024, 112025, 112026, 112027, 112028, 112029, 112030, 112031, 112032, 112033, 112034, 112035, 112037, 112038, 112039, 112040, 112041, 112042, 112043, 112044, 112045, 112046, 112047, 112048, 112049, 112050, 112052, 112053, 112054, 112055, 112056, 112057, 112058, 112059, 112060, 112061, 112062, 112063, 112064, 112065, 112066, 112067, 112068, 112069, 112070, 112071, 112072, 112073, 112074, 112075, 112076, 112077, 112078, 112079, 112080, 112081, 112082, 112083, 112084, 112085, 112086, 112087, 112088, 112089, 112090, 112091, 112092, 112093, 112094, 112095, 112096, 112098, 112099, 112100, 112101, 112102, 112103, 112105, 112106, 112107, 112108, 112109, 112110, 112111, 112112, 112113, 112114, 112115, 112116, 112117, 112118, 112119, 112120, 112121, 112122, 112123, 112124, 112125, 112126, 112127, 112128, 112130, 112131, 112133, 112134, 112135, 112136, 112137, 112139, 112140, 112141, 112142, 112143, 112144, 112145, 112146, 112147, 112148, 112149, 112151, 112152, 112153, 112154, 112155, 112156, 112157, 112158, 112160, 112161, 112162, 112163, 112164, 112166, 112167, 112168, 112169, 112170, 112171, 112172, 112173, 112175, 112176, 112177, 112178, 112179, 112180, 112181, 112182, 112183, 112184, 112185, 112186, 112187, 112188, 112190, 112191, 112192, 112195, 112196, 112197, 112198, 112199, 112200, 112201, 112202, 112203, 112204, 112205, 112206, 112207, 112208, 112209, 112210, 112211, 112212, 112213, 112214, 112215, 112216, 112217, 112218, 112219, 112220, 112221, 112222, 112223, 112224, 112225, 112227, 112228, 112229, 112230, 112231, 112232, 112233, 112234, 112236, 112237, 112238, 112239, 112240, 112241, 112242, 112243, 112244, 112245, 112246, 112247, 112248, 112249, 112250, 112251, 112252, 112253, 112254, 112255, 112256, 112257, 112258, 112260, 112261, 112262, 112263, 112264, 112265, 112266, 112267, 112268, 112269, 112270, 112271, 112272, 112273, 112274, 112275, 112276, 112277, 112278, 112279, 112280, 112281, 112282, 112283, 112285, 112286, 112287, 112288, 112289, 112290, 112291, 112292, 112293, 112294, 112295, 112296, 112298, 112299, 112300, 112301, 112302, 112303, 112304, 112305, 112306, 112307, 112308, 112309, 112310, 112311, 112312, 112313, 112314, 112315, 112316, 112317, 112318, 112319, 112320, 112321, 112322, 112323, 112324, 112325, 112326, 112327, 112328, 112329, 112330, 112332, 112333, 112334, 112335, 112337, 112339, 112340, 112341, 112342, 112343, 112344, 112346, 112347, 112348, 112349, 112352, 112353, 112354, 112355, 112356, 112357, 112358, 112359, 112360, 112361, 112363, 112364, 112365, 112366, 112368, 112370, 112371, 112372, 112373, 112374, 112375, 112376, 112377, 112379, 112380, 112381, 112382, 112383, 112384, 112385, 112386, 112388, 112389, 112390, 112391, 112392, 112393, 112394, 112395, 112396, 112397, 112398, 112399, 112400, 112401, 112402, 112403, 112404, 112405, 112406, 112407, 112408, 112409, 112410, 112411, 112412, 112413, 112414, 112415, 112416, 112417, 112418, 112419, 112420, 112421, 112422, 112423, 112424, 112425, 112426, 112427, 112428, 112429, 112430, 112431, 112432, 112433, 112434, 112435, 112436, 112437, 112438, 112439, 112441, 112442, 112443, 112444, 112445, 112446, 112447, 112448, 112449, 112450, 112451, 112452, 112453, 112454, 112455, 112456, 112457, 112458, 112460, 112461, 112462, 112463, 112464, 112465, 112468, 112470, 112471, 112472, 112474, 112475, 112476, 112477, 112478, 112479, 112481, 112482, 112483, 112484, 112485, 112486, 112487, 112488, 112489, 112490, 112491, 112492, 112493, 112494, 112495, 112496, 112498, 112499, 112501, 112502, 112503, 112504, 112505, 112506, 112507, 112508, 112509, 112510, 112511, 112512, 112513, 112514, 112515, 112516, 112517, 112518, 112519, 112520, 112521, 112522, 112523, 112524, 112525, 112526, 112527, 112528, 112529, 112530, 112531, 112532, 112533, 112534, 112535, 112536, 112537, 112538, 112539, 112540, 112541, 112542, 112543, 112544, 112545, 112546, 112547, 112548, 112549, 112550, 112551, 112552, 112553, 112554, 112555, 112556, 112557, 112559, 112560, 112561, 112562, 112563, 112564, 112565, 112566, 112568, 112569, 112570, 112571, 112572, 112573, 112575, 112576, 112579, 112580, 112581, 112582, 112583, 112584, 112585, 112586, 112587, 112588, 112590, 112591, 112592, 112593, 112594, 112595, 112596, 112597, 112598, 112599, 112600, 112601, 112602, 112603, 112604, 112605, 112606, 112607, 112608, 112609, 112610, 112611, 112612, 112613, 112614, 112615, 112616, 112617, 112618, 112619, 112620, 112621, 112622, 112623, 112624, 112625, 112626, 112627, 112628, 112629, 112630, 112631, 112632, 112633, 112635, 112637, 112638, 112639, 112640, 112641, 112643, 112645, 112646, 112648, 112649, 112651, 112652, 112653, 112655, 112656, 112657, 112658, 112659, 112661, 112662, 112664, 112666, 112669, 112670, 112672, 112673, 112674, 112676, 112678, 112679, 112680, 112681, 112682, 112683, 112684, 112686, 112687, 112688, 112689, 112690, 112692, 112693, 112694, 112695, 112696, 112697, 112698, 112699, 112700, 112702, 112703, 112704, 112705, 112707, 112708, 112709, 112712, 112714, 112717, 112718, 112719, 112720, 112721, 112722, 112723, 112725, 112726, 112727, 112728, 112729, 112731, 112732, 112735, 112736, 112737, 112738, 112739, 112740, 112741, 112743, 112744, 112745, 112747, 112748, 112749, 112750, 112751, 112752, 112753, 112754, 112755, 112756, 112758, 112759, 112760, 112761, 112762, 112763, 112764, 112765, 112766, 112767, 112768, 112769, 112770, 112771, 112772, 112773, 112774, 112775, 112776, 112778, 112779, 112780, 112781, 112782, 112783, 112784, 112785, 112786, 112787, 112788, 112789, 112790, 112791, 112792, 112793, 112794, 112796, 112797, 112798, 112801, 112802, 112803, 112804, 112806, 112807, 112808, 112809, 112810, 112811, 112812, 112813, 112814, 112815, 112816, 112817, 112818, 112819, 112820, 112822, 112823, 112824, 112825, 112826, 112827, 112828, 112829, 112830, 112831, 112832, 112833, 112834, 112835, 112837, 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Recalling Firm/
Manufacturer
Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
For Additional Information ContactUnited States Technical Services
800-227-3422
Manufacturer Reason
for Recall
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 Determined
Cause 2
Device Design
ActionThe 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 in Commerce3634 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = NKE
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