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

Recall date

November 18, 2015

Source

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

Recall number

Z-0645-2016

FDA classification

Class II

Brand / firm

Cyberonics, Inc

Sold / distributed

US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.

Why it was recalled

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the 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