Recall Z-0264-2010 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.
| Date | Nov 16, 2009 (initiated Jul 24, 2009) |
| Status | Terminated |
| Reason | Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists. |
| Root cause | Device Design |
| Action | Cyberonics sent an Important Safety Notice on July 24, 2009, to all physicians explaining the event, risks presented and recommended actions to take. Labeling updates are being developed concurrently with the notification. The firm will mail or hand-deliver the notifications via firm representatives. |
| Quantity | 9,500 programming devices |
| Distribution | Worldwide: USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.