PROPONENT DR Pacemaker — Class I medical device recall Z-0823-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-01-22, distributed nationwide. A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an in
| Recall number | Z-0823-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2024-12-12 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00802526559044, 00802526559068, 00802526559105, 00802526559143, 00802526576379, 00802526576386, 00802526576409, 00802526576416, 00802526576423, 00802526576874, 00802526576904, 00802526578014, 00802526578038, 00802526578045, 00802526578052, 00802526593307 |
| Serial numbers | 100161, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100437, 100439, 100452, 100465, 100468, 100472, 100475, 100558, 100560, 100566, 100586, 100588, 100589, 100627, 100628, 100629 and 475 more |
| Model numbers | L201, L209, L211, L221, L231 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0823-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.