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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 Systemsee related information
Date Initiated by FirmOctober 17, 2006
Date PostedJanuary 25, 2007
Recall Status1 Terminated 3 on October 02, 2009
Recall NumberZ-0341-2007
Recall Event ID 36672
PMA NumberP970003 
Product Classification VNS System Flashcards (software) - Product Code LYJ
ProductCyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
Code Information For Software v6.1: 10-005-9400 and 10-006-0900; For Software v6.1.7: 10-0007-2400 and 10-0007-2500; For Software v7.0: 10-0007-4100 and 10-0007-2500; For Software v7.1.3: 10-0007-8400 and 10-0007-8500;
FEI Number 1000117004
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
ActionFirm 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 Commerce3,538 Flashcards containing software.
DistributionWorldwide 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 CycleTPLC 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 DatabasePMAs with Product Code = LYJ
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