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U.S. Department of Health and Human Services

Class 2 Device Recall Cyberonics VNS Therapy System

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  Class 2 Device Recall Cyberonics VNS Therapy System see related information
Date Initiated by Firm October 17, 2006
Date Posted January 25, 2007
Recall Status1 Terminated 3 on October 02, 2009
Recall Number Z-0342-2007
Recall Event ID 36672
PMA Number P970003 
Product Classification VNS handheld PCs - Product Code LYJ
Product Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
Code Information For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300; For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609 and 77-0000-7000; For Handheld v7.0: 10-0007-4300; For Handheld v7.1.3: 10-0007-8600.
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
Manufacturer Reason
for Recall		 During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
FDA Determined
Cause 2		 Other
Action Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.
Quantity in Commerce 7,404 Handheld PCs pre-programmed with software.
Distribution Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, 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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