| Class 2 Device Recall Cyberonics VNS Therapy AspireSR Generator, Model 106 | |
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
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Product | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 |
Code Information |
Serial numbers 36602, 37019, 39097, 40311, 40465 |
Recalling Firm/ Manufacturer |
Cyberonics, Inc 100 Cyberonics Blvd Houston TX 77058-2069
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For Additional Information Contact | Clinical Technical Supprt 866-882-8804 |
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 |
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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.
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PMA Database | PMAs with Product Code = LYJ
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