Recall Z-3019-2017 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression
| Date | Jun 13, 2017 |
| Status | Terminated |
| Reason | Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity. |
| Root cause | Manufacturing material removal |
| Action | Affected hospitals were notified beginning on 06/13/2017 and prescribing physicians were notified beginning on 06/28/2017. Instructions for affected hospitals included examine inventory, quarantine any affected devices, return the devices, complete and return the response form. Instructions for prescribing physicians included to monitory patients frequently and perform diagnostic testing at each visit, ensure patients are using the device regularly to verify stimulation is felt, ensure patients notify their physician if stimulation changes, and complete and return the response form. |
| Quantity | 396 units |
| Distribution | Worldwide Distribution - US Nationwide and Puerto Rico and the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico. Distrib |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.