Boston Scientific Corporation: EMBLEM MRI S-ICD Model A219

Recall number

Z-0951-2021

Recalling firm

Boston Scientific Corporation

Product

EMBLEM MRI S-ICD Model A219

Status

Terminated

Initiated

2020-12-02

Posted

2021-02-05

Terminated

2022-06-23

Reason

Electrical overstress may lead to device malfunction.

Root cause

Process control

Action

Boston Scientific will communicate worldwide to physician customers via a customer letter. The customers notified will be as follows: " EMBLEM S-ICD implanting physicians/centers and/or following physicians/centers of record for the advisory population. Physicians associated with an advisory device will receive a list of affected model/serials for patients which they have implanted and/or followed or sent to their center. Boston Scientific will deliver the notification by hand or email via our sales representatives or deliver the letter via Federal Express, Courier, or email. Boston Scientific will reconcile that 100% of the identified customers /customer representatives signed for the letter, or the letter has been confirmed to be delivered. Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html

Quantity

872 units

Distribution

Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

P110042S043, P110042S058

Product code

LWS

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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