ESSENTIO DR Pacemaker — Class I medical device recall Z-0824-2025
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-0824-2025 |
|---|---|
| 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 | 00802526558924, 00802526558931, 00802526558962, 00802526558979, 00802526558986, 00802526558993, 00802526559006, 00802526559013, 00802526576317, 00802526576331, 00802526576348, 00802526576355, 00802526576812, 00802526576836, 00802526593277 |
| Serial numbers | 02093, 03254, 100262, 100265, 100266, 100267, 100273, 100274, 100275, 100277, 100280, 100281, 100283, 100284, 100286, 100287, 100288, 100289, 100291, 100294, 100295, 100299, 100300, 100301, 100387 and 475 more |
| Model numbers | L101, L111, L121, L131 |
Product
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
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-0824-2025. 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.