Recall Z-0858-2015 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
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 frequency of seizures.
| Date | Dec 23, 2014 (initiated Nov 20, 2014) |
| Status | Terminated |
| Reason | The recalled product was distributed with an incorrect serial number printed on the device's label. |
| Root cause | Labeling mix-ups |
| Action | The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices. |
| Quantity | 1 unit |
| Distribution | Distributed to PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.