Recall Z-0869-2020 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
| Date | Nov 16, 2018 |
| Status | Terminated |
| Reason | This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018. |
| Root cause | Manufacturing material removal |
| Action | The recalling firm issued Dear Doctor letters dated 11/16/2018 explaining the reason for the voluntary correction and pointing out a correction was previously initiated in June, 2017, related to this issue for devices distributed prior to October, 2015. |
| Quantity | 745 devices |
| Distribution | Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.