LivaNova USA Inc recalls Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Ho…

Recall date

November 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0868-2020

FDA classification

Class II

Brand / firm

LivaNova USA Inc

Sold / distributed

Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.