Device recall
Z-1591-2010: VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo…
FDA device recall · Class II · Cyberonics, Inc
Key facts
| Recall number (Z-number) | Z-1591-2010 |
|---|---|
| Recall event | 55446 |
| Product | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software |
| Product code | LYJ |
| Recalling firm | Cyberonics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2012 |
| 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