Class II — LivaNova USA Inc
| Recalling firm | LivaNova USA, Inc. |
|---|---|
| Registered facility | LivaNova USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. |
| Product | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode. |
| Quantity | 8 generators |
| Distribution | International distribution in the countries of Austria and United Kingdom. |
| Initiated | 2020-11-12 |
| Classified | 2020-12-04 |
| Terminated | 2023-01-12 |
| Recall number | Z-0535-2021 |
| 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 II recall — LivaNova USA Inc (Z-0535-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86776/
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