FDA Device recall Z-0936-2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System
- FDA Device
- Class II
- ongoing
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System by Boston Scientific, citing accelerated battery depletion may result in a need for device replacement earlier than expected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0936-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-02 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Reason
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Identifiers
| code_info | Serial numbers distributed in the United States: 100371 100467 100485 100548 100591 100641 100705 100710 100…Serial numbers distributed in the United States: 100371 100467 100485 100548 100591 100641 100705 100710 100717 100742 100745 100791 100866 100868 200019 200023 200031 200043 200049 200067 200125 200126 200127 200128 200129 200152 200157 200161 200163 200167 200170 200171 200176 200181 200182 200185 200186 200187 200190 200191 200192 200195 200198 200214 200217 200224 200228 200232 200236 200239 200241 200244 200247 200251 200256 200258 200261 200262 200264 200266 200269 200276 200283 200287 200290 200291 200293 200297 200300 200301 200313 200317 200330 200331 200333 200335 200341 200347 200348 200351 200358 200359 200360 200366 200367 200368 200369 200370 200372 200373 200374 200375 200378 200381 200382 200384 200386 200388 200389 200390 200391 200394 200398 200402 200403 200406 200410 200422 200423 200425 200426 200428 200431 200435 200436 200437 200441 200442 2004 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0936-2021%22
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