Device recall
Z-1072-2025: SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy…
FDA device recall · Class II · LivaNova USA, Inc.
Key facts
| Recall number (Z-number) | Z-1072-2025 |
|---|---|
| Recall event | 95435 |
| Product | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS). |
| Product code | LYJ |
| Recalling firm | LivaNova USA, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 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