VNS Therapy — Class I medical device recall Z-0561-2020
Terminated recall by LivaNova USA Inc, reported 2020-01-01, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devi
| Recall number | Z-0561-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc, Houston, TX, United States |
| Recall initiated | 2019-08-22 |
| Classified | 2019-12-20 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2024-03-28 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV |
| Quantity | 1,687 |
| UPC / GTIN / UDI-DI | 05425025750405 |
| Model numbers | 1000 |
Product
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Reason for recall
Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.
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-0561-2020. 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.