Recall Z-0645-2016 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
| Date | Jan 13, 2016 (initiated Nov 18, 2015) |
| Status | Terminated |
| Reason | Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity. |
| Root cause | Manufacturing material removal |
| Action | Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804 |
| Quantity | 29 units |
| Distribution | US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.