EMBLEM MRI S-ICD pulse generators — Class II medical device recall Z-0936-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-02-03. Accelerated battery depletion may result in a need for device replacement earlier than expected.
| Recall number | Z-0936-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2020-12-02 |
| Classified | 2021-01-28 |
| Reported by FDA | 2021-02-03 |
| Quantity | 11,296 units |
| Model numbers | A219 |
Product
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Reason for recall
Accelerated battery depletion may result in a need for device replacement earlier than expected.
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-0936-2021. 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.