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Cyberonics, Inc recalls VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Recalled May 6, 2015 · FDA recall Z-1526-2015 · Cyberonics
Hazard
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture. · FDA Class II
Units
13 units
Sold at
AR, TX, GA, CA, MI, IN, FL, AZ, NV
Description
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
Product
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Manufacturer(s)
Cyberonics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →