Device recall
Z-0858-2015: Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy…
FDA device recall · Class II · Cyberonics, Inc
Key facts
| Recall number (Z-number) | Z-0858-2015 |
|---|---|
| Recall event | 69844 |
| Product | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the… |
| Product code | LYJ |
| Recalling firm | Cyberonics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2016 |
| 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