Drug recall
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D…
FDA recall event 96063 · Class II · LivaNova USA, Inc.
Key facts
| Event ID | 96063 |
|---|---|
| Recall numbers | Z-1067-2025, Z-1068-2025 |
| Recalling firm | LivaNova USA, Inc. |
| Product type | Devices |
| Products | 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…, Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. |
| Initiation date | Jan 3, 2025 |
| Report date | Feb 5, 2025 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 1000117004 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: