Drug recall
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
FDA recall event 83873 · Class I · LivaNova USA Inc
Key facts
| Event ID | 83873 |
|---|---|
| Recall numbers | Z-0561-2020 |
| Recalling firm | LivaNova USA Inc |
| Product type | Devices |
| Products | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 22, 2019 |
| Report date | Jan 1, 2020 |
| Termination date | Mar 28, 2024 |
| 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: