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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy System

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  Class 2 Device Recall VNS Therapy System see related information
Date Initiated by Firm April 06, 2010
Date Posted May 10, 2010
Recall Status1 Terminated 3 on August 20, 2012
Recall Number Z-1591-2010
Recall Event ID 55446
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy¿ Demipulse¿ Generator, Model 103 and
VNS Therapy Demipulse Duo¿ Generator, Model 104
VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software
Code Information Model 103, VNS Therapy Demipulse Generator Model 104, VNS Therapy Demipulse Duo Generator Model 250, Programming System (version 7.0 or 7.1) 
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact
800-332-1375 Ext. 223
Manufacturer Reason
for Recall		 Battery life projection is inaccurate.
FDA Determined
Cause 2		 Software design
Action Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic. The issue can also be corrected during the initial implant procedure with the instructions provided. Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.
Quantity in Commerce Model103: 8109 units; Model 104: 1722 units; Programmers: 8891
Distribution Worldwide distribution.
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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