Class I — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Electrical overstress may lead to device malfunction. |
| Product | EMBLEM MRI S-ICD Model A219 |
| Quantity | 872 units |
| Distribution | Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries. |
| Initiated | 2020-12-02 |
| Classified | 2021-02-05 |
| Terminated | 2022-06-23 |
| Recall number | Z-0951-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Boston Scientific Corporation (Z-0951-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86902/
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