Device recall
Z-0535-2021: VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of…
FDA device recall · Class II · LivaNova USA Inc
Key facts
| Recall number (Z-number) | Z-0535-2021 |
|---|---|
| Recall event | 86776 |
| Product | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode. |
| Product code | LYJ |
| Recalling firm | LivaNova USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 12, 2023 |
| 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