EMBLEM S-ICD Model A209 — Class I medical device recall Z-0950-2021
Terminated recall by Boston Scientific Corporation, reported 2021-02-17. Electrical overstress may lead to device malfunction.
| Recall number | Z-0950-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2020-12-02 |
| Classified | 2021-02-05 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2022-06-23 |
| Countries outside the US | CA |
| Quantity | 1,953 units |
| Reason classes | device malfunction |
| Serial numbers | 104156, 104252, 104254, 104255, 104259, 104263, 104269, 104272, 104273, 104277, 104284, 104292, 104299, 104303, 104304, 104305, 104307, 104308, 104310, 104317, 104320, 104321, 104322, 104330, 104331 and 475 more |
| Model numbers | A209 |
Product
EMBLEM S-ICD Model A209
Reason for recall
Electrical overstress may lead to device malfunction.
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-0950-2021. 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.