Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO" — Class II medical device recall Z-1068-2025
Ongoing recall by LivaNova USA, Inc., reported 2025-02-05, distributed nationwide. Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component
| Recall number | Z-1068-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA, Inc., Houston, TX, United States |
| Recall initiated | 2025-01-03 |
| Classified | 2025-01-30 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, JP, KW, LT, LU, NL, NO, NZ, PA, PE, PL, PT, QA, SA, SE, SG, TR, ZA |
| Quantity | 84 units |
| UPC / GTIN / UDI-DI | 05425025750528 |
| Serial numbers | 324841, 324842, 324843, 324844, 324845, 324846, 324847, 324848, 324849, 324850, 324851, 332681, 332682, 332684, 332685, 332686, 332687, 332688, 332689, 332692, 332693, 332695, 332696, 332697, 332699 and 59 more |
| Model numbers | 1000-D |
Product
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).
Reason for recall
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
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-1068-2025. 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.