FDA Device recall Z-0935-2021
EMBLEM 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 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-0935-2021 |
| 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 S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Reason
Accelerated battery depletion may result in a need for device replacement earlier than expected.
Identifiers
| code_info | Serial numbers distributed in the US: 101624 101701 101757 101808 101835 101845 101869 101878 101946 101953…Serial numbers distributed in the US: 101624 101701 101757 101808 101835 101845 101869 101878 101946 101953 101957 101958 101960 102009 102048 102055 102060 102061 102074 102079 102081 102096 102120 102129 102177 102178 102183 102190 102194 102195 102196 102205 102220 102239 102251 102272 102277 102307 102319 102334 102383 102384 102403 102406 102409 102416 102418 102426 102428 102432 102438 102441 102452 102473 102491 102495 102505 102522 102535 102536 102540 102543 102546 102550 102557 102558 102561 102564 102565 102568 102571 102573 102574 102575 102576 102577 102578 102581 102583 102585 102586 102587 102589 102590 102593 102594 102595 102596 102597 102598 102599 102602 102603 102609 102615 102616 102617 102618 102620 102622 102625 102626 102627 102628 102630 102638 102641 102642 102645 102647 102648 102650 102651 102652 102655 102657 102658 102660 102661 102662 |
|---|
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-0935-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.