EMBLEM S-ICD — Class II medical device recall Z-0151-2023
Ongoing recall by Boston Scientific Corporation, reported 2022-11-09, distributed nationwide. There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of b
| Recall number | Z-0151-2023 |
|---|---|
| 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 | 2022-09-30 |
| Classified | 2022-10-31 |
| Reported by FDA | 2022-11-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, DE, FR, GB, LV, NL, PL, SE |
| Quantity | 7 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00802526548406 |
| Serial numbers | 169276, 169297, 169509, 169645, 169671, 169774, 169876 |
| Model numbers | A209 |
Product
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Reason for recall
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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-0151-2023. 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.