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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy AspireSR Generator

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  Class 2 Device Recall VNS Therapy AspireSR Generator see related information
Date Initiated by Firm December 18, 2015
Date Posted January 15, 2016
Recall Status1 Terminated 3 on March 02, 2017
Recall Number Z-0659-2016
Recall Event ID 72896
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy AspireSR Generator Model 106.

Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Code Information All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Clinical Technical Support
866-882-8804
Manufacturer Reason
for Recall		 Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
FDA Determined
Cause 2		 Device Design
Action The firm notified consignees of the issue via letter on 12/18/15. The letter identified the affected device, the issue involved, and actions to be taken. Physicians are to contact Clinical Technical Support at 866-882-8804 to report if a patient's generator has been disabled due to the issue identified. Users are to complete and return the effectiveness card as soon as possible. If further information is needed, customers can contact Clinical Technical Support at 866-882-8804 or via e-mail at cservices@livanova.com.
Quantity in Commerce 4,935 units
Distribution Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.
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.
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