FDA Device recall Z-0822-2025
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) by Boston Scientific, citing A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0822-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-12 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Reason
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Identifiers
| code_info | L301 - UDI-DI: 00802526559174, 00802526559181, Serial Numbers: 100752 100892 100893 100931 100932 100938 100941 100980…L301 - UDI-DI: 00802526559174, 00802526559181, Serial Numbers: 100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020 101021 101022 101024 101025 101033 101036 101037 101042 101043 101044 101046 101048 101050 101053 101059 101061 101067 101214 101218 101221 101223 101224 101225 101382 101388 101393 101400 101406 101409 101411 101412 101418 101423 101424 101427 101436 101438 101440 101442 101450 101454 101455 101457 101459 101466 101469 101472 101475 101492 101493 101494 101511 101523 101524 101525 101529 101533 101535 101537 101541 101543 101545 101546 101550 101553 101555 101559 101560 101564 101572 101575 101576 101577 101579 101581 101584 101585 101588 101590 101602 101603 101604 101605 101607 101609 101611 101619 101625 101633 101634 101637 101638 101640 101642 101644 101648 101654 101656 101659 101676 101684 101687 101700 101705 101706 101726 101741 101749 101767 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0822-2025%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.