Boston Scientific Corporation EMBLEM MRI S-ICD Model A219 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EMBLEM MRI S-ICD Model A219
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
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, 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Products Sold
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, 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Boston Scientific Corporation is recalling EMBLEM MRI S-ICD Model A219 due to Electrical overstress may lead to device malfunction.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Electrical overstress may lead to device malfunction.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026