Device recall
Z-0561-2020: VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve…
FDA device recall · Class I · LivaNova USA Inc
Key facts
| Recall number (Z-number) | Z-0561-2020 |
|---|---|
| Recall event | 83873 |
| Product | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy |
| Product code | LYJ |
| Recalling firm | LivaNova USA Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 28, 2024 |
| PMA numbers | P970003 |
| FEI number | 1000117004 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database