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U.S. Department of Health and Human Services

Class 2 Device Recall VNS System Leads

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  Class 2 Device Recall VNS System Leads see related information
Date Initiated by Firm August 02, 2007
Date Posted November 28, 2007
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-0171-2008
Recall Event ID 37912
PMA Number P970003 
Product Classification Bipolar Lead - Product Code LYJ
Product Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.
Code Information All manufactured and distributed leads.
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		 Dissolution/Fractures to the leads of the VNS Therapy System
FDA Determined
Cause 2		 Process control
Action Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.
Quantity in Commerce 21,419 units.
Distribution Worldwide Distribution - USA and countries of Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Malta, Mexico, Netherlands, Northern Ireland, Norway, Poland, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
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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