Recall Z-1526-2015 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
| Date | Apr 27, 2015 (initiated Mar 6, 2015) |
| Status | Terminated |
| Reason | The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture. |
| Root cause | Nonconforming Material/Component |
| Action | On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm. |
| Quantity | 13 units |
| Distribution | AR, TX, GA, CA, MI, IN, FL, AZ, NV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.