Cyberonics, Inc recalls VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

Recall date

March 6, 2015

Source

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

Recall number

Z-1526-2015

FDA classification

Class II

Brand / firm

Cyberonics, Inc

Sold / distributed

AR, TX, GA, CA, MI, IN, FL, AZ, NV

Why it was recalled

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.

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

What was recalled

VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.