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Cyberonics, Inc recalls Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS
Recalled December 31, 2014 · FDA recall Z-0858-2015 · Cyberonics
Hazard
The recalled product was distributed with an incorrect serial number printed on the device's label. · FDA Class II
Units
1 unit
Sold at
Distributed to PA.
Description
The recalled product was distributed with an incorrect serial number printed on the device's label.
Product
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Manufacturer(s)
Cyberonics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →