FDA-Device2020-02-05Class II
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.
LivaNova USA Inc
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.
Sold states
Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
Affected count
745 devices
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0869-2020Don't want to check this manually?
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