Device recall
Z-0346-2020: The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS)…
FDA device recall · Class II · LivaNova USA Inc
Key facts
| Recall number (Z-number) | Z-0346-2020 |
|---|---|
| Recall event | 82566 |
| Product | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals… |
| 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