Recall Z-0173-2008
Cyberonics, Inc · initiated August 2, 2007
Product
Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058.
Codes / lots: All manufactured and distributed leads.
Reason for recall
Dissolution/Fractures to the leads of the VNS Therapy System
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0173-2008
- Initiated
- August 2, 2007
- Posted by FDA
- November 28, 2007
- Terminated
- October 5, 2009
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Quantity
- 51 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, Poland, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
- Recalling firm
- Cyberonics, Inc, Houston, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0171-2008 | Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile…Dissolution/Fractures to the leads of the VNS Therapy System | 08/02/2007Terminated |
| Z-0172-2008 | Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed…Dissolution/Fractures to the leads of the VNS Therapy System | 08/02/2007Terminated |