Cyberonics, Inc recalls Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

Recall date

October 7, 2015

Source

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

Recall number

Z-0280-2016

FDA classification

Class II

Brand / firm

Cyberonics, Inc

Sold / distributed

US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.

Why it was recalled

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.

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 Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106