Recall Z-0280-2016— Cyberonics, Inc

Name: FDA recall Z-0280-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-07

Class II · Terminated

Class II FDA medical device recall by Cyberonics, Inc, initiated 2015-10-07, terminated 2017-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106. Reason: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity..

Recalling firm: Cyberonics, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-10-07
Terminated: 2017-09-06
Firm location: Houston, TX, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.