Recall Z-0171-2008 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.
| Date | Nov 28, 2007 (initiated Aug 2, 2007) |
| Status | Terminated |
| Reason | Dissolution/Fractures to the leads of the VNS Therapy System |
| Root cause | Process control |
| Action | Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients. |
| Quantity | 21,419 units. |
| Distribution | Worldwide Distribution - USA and countries of Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Malta, Mexico, Netherlands, Northern Ireland, Norway, Po |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.