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FDANovember 16, 2018device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

livanova

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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