SenTiva — Class II medical device recall Z-1073-2025
Ongoing recall by LivaNova USA, Inc., reported 2025-02-12, distributed in AK, AR, AZ, CA, CO, CT, FL, GA…. Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated c
| Recall number | Z-1073-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA, Inc., Houston, TX, United States |
| Recall initiated | 2024-12-12 |
| Classified | 2025-01-31 |
| Reported by FDA | 2025-02-12 |
| Distributed | AK, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | GB |
| Quantity | 48 |
| UPC / GTIN / UDI-DI | 05425025750405 |
| Model numbers | 1000C |
Product
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Reason for recall
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
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-1073-2025. 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.