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U.S. Department of Health and Human Services

Class 2 Device Recall ParaMount Mini GPS

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  Class 2 Device Recall ParaMount Mini GPS see related information
Date Initiated by Firm January 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 08, 2005
Recall Number Z-0600-04
Recall Event ID 28210
510(K)Number K033134  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .018" REF PMB 8-6-21-80
Code Information Lots 262849 through 445216
Recalling Firm/
Manufacturer		 ev3, Inc.
651 Campus Dr
Saint Paul MN 55112-3495
Manufacturer Reason
for Recall		 After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
FDA Determined
Cause 2		 Other
Action A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s representatives.
Quantity in Commerce 446
Distribution The product was distributed nationwide in the United States and internationally to China and Ireland.
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.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = EV3 INC
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