VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800… — Class II medical device recall Z-1118-2020
Terminated recall by LivaNova USA Inc, reported 2020-02-19, distributed in FL, GA, KS, MO, UT. Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does
| Recall number | Z-1118-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc, Houston, TX, United States |
| Recall initiated | 2019-08-13 |
| Classified | 2020-02-10 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2022-05-18 |
| Distributed | FL, GA, KS, MO, UT |
| Quantity | 6 generators |
| Model numbers | 1000, 183960, 194980, 204460, 204700, 206720, 213290 |
Product
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
Reason for recall
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
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-1118-2020. 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.