Z-0951-2021 Class I Terminated
FDA device recall Z-0951-2021 was initiated by Boston Scientific Corporation on December 2, 2020 and is designated Class I. Reason for recall: Electrical overstress may lead to device malfunction. The recall status is terminated (terminated June 23, 2022). Affected quantity: 872 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- December 2, 2020
- Termination Date
- June 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 872 units
Product Description
EMBLEM MRI S-ICD Model A219
Reason for Recall
Electrical overstress may lead to device malfunction.
Distribution Pattern
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Code Information
Serial numbers: 100641, 200266, 200291, 200317, 200347, 200348, 200359, 200368, 200369, 200375, 200378, 200431, 200479, 200481, 200631, 200762, 200786, 200787, 200818, 200821, 200822, 200838, 200848, 200854, 200874, 200888, 200889, 200896, 200899, 200905, 200910, 200914, 200919, 200925, 200927, 200965, 200966, 200979, 200986, 200990, 200991, 200992, 200995, 200996, 200997, 201012, 201016, 201021, 201024, 201031, 201036, 201044, 201050, 201103, 201131, 201133, 201135, 201137, 201157, 201172, 201180, 201182, 201188, 201193, 201264, 201333, 201338, 201353, 201424, 201434, 201460, 201464, 201476, 201491, 201498, 201501, 201510, 201512, 201513, 201514, 201515, 201516, 201517, 201521, 201525, 201544, 201545, 201548, 201551, 201555, 201556, 201557, 201558, 201571, 201600, 201651, 201655, 201662, 201709, 201711, 201713, 201714, 201727, 201747, 201748, 202039, 202042, 202062, 202063, 202065, 202083, 202094, 202833, 203238, 203246, 203249, 203285, 203293, 203301, 203302, 203307, 203311, 203330, 203339, 203341, 203346, 203348, 203362, 203380, 203394, 203397, 203408, 203410, 203413, 203414, 203430, 203438, 203443, 203463, 203480, 203484, 203486, 203492, 203495, 203496, 203498, 203499, 203500, 203502, 203503, 203504, 203505, 203525, 203539, 203541, 203544, 203555, 203557, 203589, 203598, 203611, 204071, 204085, 204111, 204116, 204135, 204145, 204175, 204191, 204206, 204210, 204212, 204236, 204243, 204250, 204255, 204449, 205608, 205613, 205618, 205619, 205620, 205627, 205647, 205684, 205686, 205712, 205727, 205730, 205739, 205760, 205769, 205776, 205781, 205886, 205891, 205904, 205908, 205928, 205931, 205943, 205956, 205965, 205969, 205981, 205985, 205988, 206021, 206025, 206036, 206045, 206102, 206110, 206332, 206333, 206338, 206373, 206403, 206408, 206413, 206417, 206426, 206429, 206472, 210777, 210847, 210848, 210914, 211697, 211722, 211734, 211737, 211756, 211786, 211804, 213096, 213333, 214197, 214213, 214254, 214269, 214271, 214272, 214275, 214287, 214292, 214295, 214300, 214305, 214348, 214349, 214350, 214370, 214393, 214405, 214430, 214435, 214448, 214451, 214455, 214460, 214568, 214578, 214582, 214583, 214603, 214611, 214635, 214636, 214641, 214653, 214796, 215109, 215112, 215113, 215130, 215140, 215158, 215159, 215162, 215164, 215191, 215202, 215237, 215349, 215357, 215358, 215378, 215389, 215394, 215395, 215396, 215399, 215401, 215409, 215410, 215434, 215449, 215457, 215458, 215460, 215466, 215469, 215476, 215478, 215482, 215484, 215487, 215489, 215496, 215498, 215503, 215512, 215514, 215521, 215534, 215543, 215546, 215557, 215559, 215561, 215571, 215575, 215581, 215583, 215586, 215590, 215591, 215596, 215598, 215599, 215600, 215601, 215604, 215618, 215622, 215631, 215645, 215646, 215649, 215659, 215661, 215662, 215664, 215665, 215670, 215672, 215674, 215675, 215684, 215685, 215686, 215687, 215688, 215690, 215691, 215700, 215704, 215706, 216554, 216560, 216573, 216664, 216694, 218089, 218094, 218113, 218253, 218255, 218265, 218290, 218331, 218409, 218432, 218458, 218464, 218526, 218705, 218710, 218718, 218721, 218740, 218741, 218749, 218765, 218797, 218806, 219237, 219254, 219255, 219263, 219287, 219364, 219402, 219411, 219415, 219422, 219423, 219425, 219430, 219432, 219434, 219437, 219440, 219446, 219450, 219453, 219473, 219476, 219478, 219480, 219481, 219485, 219486, 219535, 219682, 219746, 219784, 219824, 219831, 219836, 219843, 219846, 219854, 219855, 219856, 219857, 219860, 219868, 219869, 219870, 219879, 219886, 219891, 219930, 220006, 220026, 220033, 205771, 100294, 100297, 100303, 100500, 100565, 100724, 100737, 100749, 100761, 100865, 200289, 200315, 200338, 200885, 200926, 200993, 201023, 201042, 201496, 201497, 201508, 201547, 201621, 201633, 201649, 201654, 203444, 203526, 203616, 203660, 206038, 206047, 206381, 206382, 210752, 210758, 210845, 210917, 212845, 212850, 214616, 214679, 214890, 215099, 215153, 215450, 215452, 215492, 215502, 215506, 215579, 215640, 215692, 215705, 216545, 216547, 216564, 216623, 216639, 218000, 218092, 218212, 218257, 218719, 219238, 219439, 219667, 219789, 219851, 219874, 219922, 219980, 100295, 100296, 100298, 100299, 100300, 100301, 100302, 100450, 100473, 100477, 100479, 100491, 100508, 100514, 100518, 100520, 100555, 100569, 100573, 100615, 100626, 100673, 100695, 100759, 100760, 100766, 100869, 100880, 200282, 200295, 200305, 200316, 200327, 200332, 200764, 200780, 200789, 200797, 200809, 200820, 200860, 200863, 200870, 200886, 200900, 200912, 200967, 200985, 200999, 201038, 201053, 201121, 201412, 201489, 201495, 201499, 201500, 201503, 201511, 201518, 201522, 201523, 201530, 201543, 201546, 201549, 201559, 201566, 201574, 201576, 201588, 201630, 201650, 201656, 201669, 201682, 201694, 201710, 201719, 201728, 201729, 201803, 201969, 202090, 202435, 203334, 203403, 203538, 203550, 203562, 203570, 203571, 203581, 203588, 203594, 203605, 203639, 203640, 203644, 203662, 205379, 205660, 205862, 205890, 205893, 205899, 205929, 205935, 205937, 205982, 205996, 206007, 206042, 206043, 206052, 206053, 206070, 206092, 206100, 206340, 206371, 206377, 206378, 206384, 206385, 206396, 206401, 206404, 206405, 206407, 206409, 206420, 206422, 206439, 206441, 210731, 210732, 210763, 210830, 210839, 210840, 210842, 210849, 210850, 210854, 210915, 211752, 211780, 212033, 212093, 212100, 212114, 212715, 212849, 212870, 213095, 214273, 214366, 214396, 214566, 214570, 214579, 214581, 214599, 214609, 214612, 214626, 214627, 214630, 214631, 214632, 214633, 214634, 214639, 214640, 214643, 214644, 214646, 214650, 214655, 214685, 214792, 214794, 214797, 214798, 214830, 214862, 214867, 214868, 214871, 214872, 214873, 214874, 214875, 214876, 214877, 214880, 214881, 214885, 214887, 214893, 214895, 214896, 214897, 214906, 214907, 214908, 215093, 215141, 215146, 215152, 215175, 215178, 215192, 215206, 215241, 215261, 215317, 215365, 215369, 215391, 215441, 215465, 215467, 215470, 215480, 215481, 215483, 215488, 215490, 215491, 215493, 215495, 215497, 215499, 215500, 215504, 215513, 215515, 215524, 215540, 215545, 215549, 215558, 215569, 215576, 215578, 215580, 215584, 215585, 215593, 215595, 215607, 215629, 215638, 215650, 215653, 215657, 215660, 215666, 215667, 215669, 215671, 215676, 215677, 215681, 215682, 215689, 215697, 215698, 215703, 216544, 216549, 216552, 216559, 216565, 216566, 216570, 216617, 216620, 216621, 216622, 216636, 216637, 216641, 216642, 216687, 216689, 216853, 216859, 217923, 218076, 218081, 218084, 218087, 218107, 218110, 218119, 218120, 218130, 218134, 218135, 218140, 218148, 218174, 218213, 218214, 218251, 218262, 218307, 218370, 218403, 218408, 218415, 218428, 218429, 218435, 218441, 218444, 218477, 218706, 218782, 218792, 218809, 218960, 219236, 219288, 219323, 219334, 219404, 219408, 219409, 219413, 219427, 219429, 219443, 219459, 219474, 219475, 219518, 219675, 219736, 219796, 219802, 219808, 219820, 219821, 219839, 219842, 219844, 219845, 219849, 219861, 219863, 219864, 219866, 219871, 219876, 219882, 219923, 219952