Recall Z-0659-2016 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
| Date | Jan 15, 2016 (initiated Dec 18, 2015) |
| Status | Terminated |
| Reason | Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled. |
| Root cause | Device Design |
| Action | The firm notified consignees of the issue via letter on 12/18/15. The letter identified the affected device, the issue involved, and actions to be taken. Physicians are to contact Clinical Technical Support at 866-882-8804 to report if a patient's generator has been disabled due to the issue identified. Users are to complete and return the effectiveness card as soon as possible. If further information is needed, customers can contact Clinical Technical Support at 866-882-8804 or via e-mail at cservices@livanova.com. |
| Quantity | 4,935 units |
| Distribution | Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.