ACCOLADE DR Pacemaker — Class I medical device recall Z-0822-2025
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-0822-2025 |
|---|---|
| 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 | 00802526559174, 00802526559181, 00802526559228, 00802526559235, 00802526559242, 00802526559259, 00802526559266, 00802526559273, 00802526576461, 00802526576485, 00802526578076, 00802526578083, 00802526592201 |
| Serial numbers | 0510, 100290, 100393, 100394, 100399, 100402, 100404, 100406, 100407, 100408, 100410, 100411, 100412, 100413, 100415, 100416, 100417, 100419, 100420, 100422, 100423, 100424, 100425, 100428, 100429 and 475 more |
| Model numbers | L301, L311, L321, L331 |
Product
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
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-0822-2025. 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.