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LivaNova USA Inc recalls Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., H
Recalled February 5, 2020 · FDA recall Z-0868-2020 · LivaNova USA
Hazard
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. · FDA Class II
Units
106 devices
Sold at
Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
Description
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.
Product
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Manufacturer(s)
LivaNova USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →