Recalls / —

—#184795

Product

EMBLEM MRI S-ICD Model A219

FDA product code

LWS — Implantable Cardioverter Defibrillator (Non-Crt)

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P110042S043, P110042S058

Affected lot / code info

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

Why it was recalled

Electrical overstress may lead to device malfunction.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm

Boston Scientific Corporation

Address

4100 Hamline Ave N, Bldg 3, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern

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

Timeline

Recall initiated

2020-12-02

Posted by FDA

2021-02-05

Terminated

2022-06-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184795. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.