Class 1 Device Recall INLIVEN CRTP

• Date Initiated by Firm: June 03, 2021
• Date Posted: July 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2020-2021
• Recall Event ID: 88107
• PMA Number: P030005
• Product Classification: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
• Product: INLIVEN 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, 112838, 112839, 112840, 112841, 112842, 112843, 112844, 112845, 112846, 112847, 112848, 112849, 112851, 112852, 112853, 112854, 112855, 112856, 112857, 112858, 112860, 112861, 112862, 112863, 112864, 112865, 112866, 112868, 112869, 112870, 112871, 112872, 112873, 112874, 112875, 112877, 112878, 112879, 112880, 112881, 112882, 112883, 112884, 112885, 112886, 112887, 112888, 112889, 112890, 112891, 112892, 112894, 112895, 112896, 112897, 112898, 112899, 112900, 112902, 112903, 112904, 112905, 112906, 112907, 112908, 112909, 112910, 112911, 112912, 112913, 112914, 112915, 112916, 112917, 112918, 112919, 112920, 112921, 112922, 112923, 112924, 112925, 112926, 112927, 112928, 112929, 112930, 112931, 112932, 112934, 112935, 112936, 112937, 112938, 112939, 112940, 112941, 112942, 112943, 112944, 112945, 112946, 112947, 112948, 112949, 112950, 112951, 112952, 112954, 112955, 112957, 112959, 112960, 112961, 112962, 112963, 112964, 112966, 112967, 112968, 112969, 112970, 112971, 112972, 112974, 112975, 112976, 112977, 112978, 112979, 112980, 112981, 112983, 112984, 112985, 112986, 112987, 112988, 112989, 112990, 112991, 112992, 112993, 112995, 112996, 112997, 112998, 113000, 113001, 113004, 113005, 113006, 113007, 113008, 113010, 113011, 113013, 113014, 113015, 113016, 113017, 113018, 113019, 113020, 113021, 113022, 113023, 113024, 113026, 113027, 113028, 113029, 113030, 113031, 113032, 113033, 113034, 113035, 113036, 113037, 113038, 113039, 113040, 113044, 113045, 113046, 113047, 113048, 113049, 113050, 113051, 113052, 113053, 113054, 113055, 113056, 113060, 113062, 113063, 113064, 113065, 113066, 113067, 113068, 113069, 113071, 113072, 113073, 113074, 113075, 113076, 113077, 113078, 113080, 113082, 113083, 113087, 113088, 113089, 113090, 113091, 113092, 113093, 113094, 113095, 113096, 113097, 113098, 113099, 113100, 113103, 113104, 113105, 113106, 113107, 113108, 113110, 113111, 113112, 113114, 113115, 113116, 113118, 113119, 113120, 113121, 113122, 113123, 113124, 113125, 113127, 113128, 113129, 113130, 113131, 113132, 113133, 113134, 113135, 113136, 113138, 113139, 113140, 113141, 113142, 113145, 113146, 113147, 113148, 113149, 113150, 113151, 113152, 113153, 113154, 113155, 113156, 113157, 113158, 113160, 113161, 113162, 113163, 113164, 113165, 113167, 113168, 113169, 113170, 113171, 113172, 113173, 113174, 113176, 113177, 113179, 113180, 113181, 113183, 113184, 113185, 113186, 113187, 113188, 113189, 113190, 113191, 113193, 113194, 113195, 113196, 113197, 113198, 113200, 113201, 113202, 113204, 113205, 113206, 113207, 113208, 113209, 113210, 113211, 113213, 113214, 113215, 113216, 113217, 113218, 113219, 113220, 113221, 113222, 113223, 113224, 113225, 113226, 113227, 113228, 113229, 113230, 113231, 113232, 113233, 113234, 113235, 113236, 113238, 113239, 113240, 113241, 113242, 113244, 113246, 113247, 113248, 113249, 113250, 113251, 113253, 113255, 113257, 113258, 113259, 113260, 113261, 113262, 113263, 113264, 113265, 113266, 113267, 113268, 113269, 113270, 113271, 113272, 113273, 113274, 113275, 113276, 113277, 113278, 113279, 113280, 113281, 113283, 113284, 113285, 113287, 113288, 113289, 113290, 113291, 113292, 113293, 113298, 113299, 113300, 113301, 113303, 113304, 113305, 113306, 113307, 113308, 113309, 113310, 113311, 113312, 113313, 113314, 113315, 113316, 113317, 113318, 113319, 113323, 113324, 113325, 113326, 113327, 113328, 113329, 113330, 113331, 113332, 113333, 113336, 113337, 113338, 113339, 113340, 113341, 113342, 113343, 113344, 113345, 113346, 113347, 113348, 113349, 113350, 113351, 113352, 113353, 113354, 113355, 113357, 113358, 113359, 113360, 113361, 113362, 113363, 113364, 113366, 113367, 113368, 113369, 113370, 113371, 113372, 113373, 113375, 113376, 113378, 113379, 113380, 113381, 113382, 113383, 113384, 113385, 113386, 113387, 113388, 113389, 113390, 113391, 113393, 113394, 113395, 113396, 113397, 113398, 113399, 113400, 113402, 113403, 113404, 113405, 113406, 113407, 113408, 113410, 113411, 113412, 113413, 113414, 113415, 113418, 113419, 113420, 113422, 113423, 113424, 113425, 113426, 113427, 113428, 113429, 113430, 113431, 113433, 113434, 113435, 113436, 113437, 113439, 113440, 113441, 113442, 113443, 113445, 113446, 113447, 113448, 113450, 113451, 113452, 113453, 113454, 113455, 113457, 113458, 113459, 113461, 113462, 113463, 113464, 113465, 113466, 113467, 113468, 113470, 113471, 113472, 113473, 113474, 113475, 113476, 113477, 113478, 113479, 113480, 113481, 113482, 113483, 113484, 113486, 113487, 113488, 113489, 113490, 113491, 113492, 113493, 113494, 113495, 113496, 113497, 113498, 113499, 113500, 113501, 113502, 113503, 113505, 113506, 113507, 113508, 113510, 113512, 113514, 113515, 113516, 113517, 113518, 113519, 113520, 113521, 113522, 113523, 113524, 113525, 113527, 113528, 113529, 113530, 113531, 113532, 113533, 113534, 113535, 113536, 113537, 113538, 113539, 113540, 113541, 113542, 113543, 113544, 113545, 113547, 113548, 113549, 113551, 113552, 113554, 113555, 113556, 113557, 113558, 113559, 113560, 113561, 113562, 113563, 113564, 113565, 113566, 113567, 113568, 113569, 113570, 113571, 113572, 113574, 113575, 113576, 113577, 113578, 113579, 113580, 113581, 113582, 113583, 113584, 113585, 113586, 113587, 113588, 113589, 113590, 113591, 113592, 113593, 113594, 113595, 113596, 113597, 113598, 113599, 113600, 113601, 113602, 113603, 113604, 113605, 113606, 113607, 113608, 113609, 113610, 113611, 113612, 113613, 113615, 113616, 113617, 113618, 113620, 113621, 113623, 113624, 113625, 113626, 113627, 113628, 113629, 113630, 113631, 113632, 113633, 113635, 113636, 113637, 113639, 113640, 113641, 113643, 113644, 113645, 113646, 113648, 113649, 113650, 113651, 113652, 113653, 113654, 113655, 113656, 113657, 113658, 113659, 113660, 113662, 113663, 113665, 113666, 113667, 113668, 113669, 113671, 113672, 113673, 113674, 113675, 113676, 113677, 113678, 113679, 113680, 113681, 113682, 113684, 113685, 113686, 113687, 113688, 113689, 113691, 113692, 113693, 113694, 113695, 113696, 113697, 113699, 113700, 113702, 113703, 113704, 113705, 113707, 113708, 113709, 113710, 113711, 113713, 113714, 113715, 113716, 113717, 113718, 113720, 113721, 113722, 113723, 113724, 113725, 113726, 113727, 113728, 113729, 113730, 113731, 113732, 113733, 300712, 300713, 300714, 300716, 300717, 300718, 300719, 300720, 300721, 300722, 300723, 300724, 300725, 300726, 300727, 300728, 300730, 300731, 300732, 300733, 300734, 300735, 300736, 300737, 300738, 300739, 300740, 300741, 300742, 300743, 300744, 300745, 300746, 300747, 300748, 300749, 300750, 300751, 300752, 300753, 300754, 300755, 300756, 300757, 300758, 300759, 300760, 300762, 300763, 300764, 300765, 300766, 300767, 300768, 300770, 300771, 300772, 300773, 300774, 300775, 300776, 300778, 300779, 300780, 300781, 300782, 300783, 300784, 300785, 300786, 300787, 300788, 300789, 300790, 300791, 300792, 300793, 300794, 300795, 300796, 300797, 300798, 300799, 300800, 300801, 300802, 300803, 300805, 300806, 300807, 300808, 300809, 300810, 300812, 300813, 300814, 300815, 300817, 300818, 300819, 300820, 300821, 300822, 300823, 300824, 300825, 300826, 300828, 300829, 300830, 300831, 300832, 300833, 300834, 300835, 300836, 300842, 300844, 300845, 300846, 300847, 300848, 300849, 300850, 300851, 300852, 300853, 300854, 300855, 300857, 300858, 300859, 300861, 300863, 300864, 300865, 300866, 300867, 300868, 300869, 300870, 300871, 300872, 300873, 300874, 300875, 300876, 300877, 300878, 300879, 300880, 300881, 300882, 300883, 300884, 300885, 300886, 300887, 300888, 300889, 300890, 300891, 300892, 300894, 300896, 300897, 300898, 300899, 300900, 300901, 300902, 300903, 300904, 300905, 300906, 300907, 300908, 300909, 300910, 300911, 300912, 300913, 300914, 300915, 300916, 300917, 300918, 300919, 300920, 300921, 300922, 300923, 300925, 300926, 300927, 300929, 300930, 300931, 300932, 300933, 300934, 300936, 300937, 300938, 300939, 300940, 300941, 300942, 300943, 300944, 300945, 300946, 300947, 300948, 300949, 300950, 300951, 300953, 300954, 300956, 300957, 300958, 300959, 300960, 300961, 300962, 300963, 300964, 300965, 300966, 300967, 300968, 300969, 300970, 300971, 300972, 300973, 300974, 300975, 300976, 300977, 300978, 300979, 300981, 300982, 300983, 300984, 300985, 300986, 300987, 300988, 300989, 300990, 300992, 300993, 300994, 300995, 300996, 300997, 300998, 300999, 301000, 301001, 301002, 301003, 301004, 301005, 301006, 301007, 301008, 301009, 301010, 301011, 301012, 301013, 301014, 301015, 301016, 301018, 301019, 301020, 301021, 301022, 301023, 301024, 301025, 301026, 301027, 301028, 301029, 301030, 301031, 301032, 301033, 301034, 301035, 301037, 301038, 301039, 301040, 301041, 301042, 301043, 301044, 301045, 301046, 301049, 301050, 301051, 301052, 301053, 301054, 301055, 301056, 301057, 301058, 301060, 301061, 301062, 301063, 301064, 301065, 301066, 301067, 301068, 301069, 301070, 301071, 301073, 301074, 301075, 301076, 301077, 301078, 301079, 301080, 301081, 301082, 301083, 301084, 301086, 301087, 301088, 301089, 301090, 301091, 301092, 301093, 301094, 301095, 301096, 301097, 301099, 301100, 301101, 301102, 301103, 301104, 301105, 301106, 301107, 301108, 301110, 301111, 301112, 301113, 301114, 301115, 301116, 301117, 301118, 301119, 301120, 301122, 301123, 301124, 301125, 301126, 301127, 301128, 301129, 301130, 301131, 301133, 301134, 301135, 301136, 301137, 301138, 301139, 301140, 301141, 301142, 301143, 301144, 301145, 301146, 301147, 301148, 301149, 301150, 301151, 301153, 301154, 301156, 301157, 301158, 301159, 301161, 301162, 301163, 301165, 301166, 301167, 301169, 301170, 301171, 301172, 301173, 301174, 301175, 301176, 301177, 301178, 301179, 301180, 301181, 301182, 301183, 301184, 301186, 301187, 301188, 301189, 301190, 301191, 301192, 301193, 301194, 301195, 301196, 301197, 301198, 301199, 301200, 301202, 301203, 301204, 301205, 301206, 301207, 301208, 301209, 301210, 301211, 301212, 301213, 301214, 301215, 301216, 301217, 301218, 301219, 301220, 301221, 301222, 301223, 301224, 301225, 301226, 301228, 301229, 301230, 301231, 301232, 301234, 301235, 301236, 301237, 301238, 301239, 301240, 301241, 301242, 301243, 301244, 301245, 301246, 301247, 301248, 301249, 301250, 301251, 301252, 301253, 301279, 301304, 301308, 301309, 301310, 301311, 301312, 301313, 301314, 301315, 301316, 301317, 301318, 301319, 301320, 301321, 301322, 301323, 301324, 301325, 301326, 301327, 301328, 301329, 301330, 301331, 301332, 301333, 301334, 301336, 301337, 301338, 301339, 301340, 301341, 301342, 301343, 301344, 301346, 301347, 301348, 301350, 301351, 301352, 301355, 301356, 301357, 301372, 301375, 301379, 301380, 301381, 301384, 301386, 301389, 301391, 301392, 301396, 301397, 301399, 301400, 301401, 301402, 301403, 301404, 301405, 301406, 301407, 301408, 301409, 301410, 301412, 301413, 301415, 301416, 301417, 301418, 301419, 301420, 301421, 301422, 301423, 301424, 301425, 301426, 301427, 301428, 301429, 301430, 301431, 301432, 301433, 301434, 301435, 301436, 301437, 301438, 301441, 301442, 301443, 301444, 301445, 301446, 301447, 301448, 301449, 301450, 301452, 301453, 301454, 301455, 301456, 301457, 301458, 301459, 301460, 301461, 301462, 301469, 301470, 301492
• 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: 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: 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 in Commerce: 3634 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.