FDA Device recall Z-0826-2025
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) 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-0826-2025 |
| 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
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
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 | U125 - UDI-DI: 00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, Serial Numbers: 100319…U125 - UDI-DI: 00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, Serial Numbers: 100319 100323 100329 100331 100333 100379 100380 100384 100385 100386 100390 100392 100439 100448 100452 100453 100462 100466 100467 100480 100481 100482 100485 100486 100495 100496 100497 100498 100499 100500 100502 100505 100506 100510 100514 100515 100517 100518 100524 100526 100539 100540 100541 100546 100548 100549 100552 100585 100650 100653 100656 100657 100658 100690 100692 100693 100697 100699 100700 100701 100703 100707 100711 100716 100721 100722 100723 100725 100726 100730 100731 100733 100735 100740 100743 100746 100748 100751 100754 100755 100756 100757 100758 100759 100760 100761 100763 100764 100767 100768 100770 100772 100774 100775 100776 100777 100778 100779 100780 100781 100784 100786 100788 100789 100790 100792 100793 100799 100801 100802 100803 100805 100813 100814 100818 100823 100830 100833 100843 100846 100854 100864 100866 100870 100871 100873 100877 |
|---|
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-0826-2025%22
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