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U.S. Department of Health and Human Services

Class 2 Device Recall Cyberonics VNS Therapy AspireSR Generator, Model 106

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  Class 2 Device Recall Cyberonics VNS Therapy AspireSR Generator, Model 106 see related information
Date Initiated by Firm November 18, 2015
Date Posted January 13, 2016
Recall Status1 Terminated 3 on September 06, 2017
Recall Number Z-0645-2016
Recall Event ID 72698
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Code Information Serial numbers 36602, 37019, 39097, 40311, 40465
Recalling Firm/
Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Clinical Technical Supprt
Manufacturer Reason
for Recall
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 Determined
Cause 2
Manufacturing material removal
Action Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804
Quantity in Commerce 29 units
Distribution US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.