Device recall
Z-0555-2018: VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended…
FDA device recall · Class II · Cyberonics, Inc
Key facts
| Recall number (Z-number) | Z-0555-2018 |
|---|---|
| Recall event | 78914 |
| Product | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset… |
| Product code | LYJ |
| Recalling firm | Cyberonics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2018 |
| 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