Device recall
Z-1118-2020: VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000…
FDA device recall · Class II · LivaNova USA Inc
Key facts
| Recall number (Z-number) | Z-1118-2020 |
|---|---|
| Recall event | 84710 |
| Product | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1) |
| Product code | LYJ |
| Recalling firm | LivaNova USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2022 |
| 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