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All product recalls associated with Cyberonics, Inc.
Total Recalls
14
Past Year
0
Class I (Serious)
0
Most Recent
Nov 2014
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The recalled product was distributed with an incorrect serial number printed on the device's label.
Tucker Rocky Distribution (Tucker Rocky) is recalling certain models of Cyber River Road Grateful Dead U-6 motorcycle helmets, small and medium sizes, manufactured in December 2012. During testing, the affected helmets failed to conform to the impact attenuation requirements of Federal Motor Vehicle Safety Standard No. 218, "Motorcycle Helmets."
Tucker Rocky Distribution is recalling certain Cyber U-72 size large motorcyle helmets manufactured in June 2012. The affected helmets fail to conform to the impact requirements of Federal Motor Vehicle Safety Standard No. 218, "Motorcycle Helmets."
Under certain conditions, product's battery life can be reduced.
Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists.
Sterility of product cannot be assured
Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.
A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input.
Dissolution/Fractures to the leads of the VNS Therapy System
Dissolution/Fractures to the leads of the VNS Therapy System
Dissolution/Fractures to the leads of the VNS Therapy System
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician