Recall Z-0280-2016 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
| Date | Nov 17, 2015 (initiated Oct 7, 2015) |
| Status | Terminated |
| Reason | Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity. |
| Root cause | Manufacturing material removal |
| Action | Cyberonics sent written recall notifications beginning October 14, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. The notice also directs customers to contact Cyberonics to schedule additional on-site troubleshooting. The on-site troubleshooting proposed by Cyberonics will utilize a feature included within the Model 250 Version 9.0 Programming Software as an alternate method of verifying heart rate and determining that the appropriate heart beat sensitivity setting is programmed. The Version 9.0 software displays a |
| Quantity | 27 units |
| Distribution | US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.