Recall Z-0642-2010 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change stimulation settings The Demipulse Generator is an implantable multiprogrammable, device that delivers electrical signals to the vagus nerve. E
| Date | Jan 14, 2010 (initiated Nov 20, 2009) |
| Status | Terminated |
| Reason | Under certain conditions, product's battery life can be reduced. |
| Root cause | Other |
| Action | Firm sent "An Important Safety Notice" letter to all physicians explaining events, risks presented and recommended actions. Letter was mailed November 20, 2009. Physicians should complete and return the effectiveness card as soon as possible to acknowledge that you have read and understood the Safety Alert Letter. If further information is needed, customers in the US can contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com. |
| Quantity | 8,667 units |
| Distribution | Worldwide Distribution -- USA, Argentina, Austria, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Iceland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Panama, Portugal, Republic of Germany, Saudi Arabia, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.