FDA Device recall Z-0824-2025
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131) 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-0824-2025 |
| 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
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
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 | L101 - UDI-DI: 00802526558924 and 00802526558931, 00802526576317, 00802526576812, Serial Numbers: 100683 100690 100697…L101 - UDI-DI: 00802526558924 and 00802526558931, 00802526576317, 00802526576812, Serial Numbers: 100683 100690 100697 100701 100702 100703 100705 100706 100723 100724 100726 100727 100735 100740 100741 100762 100792 101029 101217 101364 101367 101370 101385 101392 101404 101408 101425 101428 101441 101480 101498 101499 101512 101558 101566 101570 101578 101595 101624 101673 101680 101694 101716 101721 101724 101731 101732 101742 101747 101757 101774 101775 101777 101784 101793 101799 101801 101810 101813 101830 101832 101836 101845 101854 101859 101860 101861 101863 101865 101870 101871 101874 101880 101898 101902 101903 101914 101921 101933 101936 101939 101950 101952 101956 101960 101961 101969 101971 101976 101993 102000 102001 102005 102021 102029 102037 102038 102041 102046 102060 102062 102069 102075 102077 102099 102103 102120 102127 102168 102174 102181 102212 102219 102225 102234 102249 102272 102275 102402 102403 102412 102433 102457 102466 102504 102537 102541 102568 102600 |
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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-0824-2025%22
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