VNS Therapy SENTIVA DUO # 1000-D — Class II medical device recall Z-0535-2021
Terminated recall by LivaNova USA Inc, reported 2020-12-16. During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Num
| Recall number | Z-0535-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc, Houston, TX, United States |
| Recall initiated | 2020-11-12 |
| Classified | 2020-12-04 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2023-01-12 |
| Countries outside the US | AT, GB |
| Quantity | 8 generators |
| Serial numbers | 310068, 310348, 310351, 310353, 310380, 310443, 310531, 311298 |
| Model numbers | 1000-D |
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.
Reason for recall
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
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-0535-2021. 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.