Home / Recalls / Medical Devices
Cyberonics, Inc recalls Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Recalled January 27, 2016 · FDA recall Z-0645-2016 · Cyberonics
Hazard
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. · FDA Class II
Units
29 units
Sold at
US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Description
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.
Product
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Manufacturer(s)
Cyberonics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →