Device recall
Z-0532-2022: Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model…
FDA device recall · Class II · LivaNova USA, Inc.
Key facts
| Recall number (Z-number) | Z-0532-2022 |
|---|---|
| Recall event | 89335 |
| Product | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter) |
| Product code | LYJ |
| Recalling firm | LivaNova USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 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