FDA Device recall Z-0823-2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MR…
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MR… 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-0823-2025 |
| 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
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
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 | L201 - UDI-DI: 00802526559044, 00802526578014, 00802526576379, 00802526576874, Serial Number: 760500 100707 100788 1007…L201 - UDI-DI: 00802526559044, 00802526578014, 00802526576379, 00802526576874, Serial Number: 760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805 715831 715842 715847 715854 715886 715905 715907 715912 715934 715949 715953 715981 715986 715991 715993 716002 716005 716007 716011 716016 716028 716044 716045 716054 716063 716066 716081 716097 716106 716147 716148 716162 716163 716171 716182 716183 716190 716194 716205 716208 716228 716237 716239 716247 716250 716255 716256 716260 716267 716282 716288 716289 716290 716291 716292 716306 716309 716315 716317 716333 716342 716346 716360 716375 716380 716396 716407 716410 716419 716421 716423 716424 716426 716433 716435 716443 716455 716473 716514 716543 716545 716572 716605 716610 716629 716641 716680 716715 716721 716727 716750 716759 716760 716769 716779 716803 716836 716839 716841 716845 716868 716990 716994 716997 717000 717009 717018 717034 717040 717 |
|---|
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-0823-2025%22
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