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U.S. Department of Health and Human Services

Class 2 Device Recall ev3 Primus GPS Biliary Stent and Delivery System

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  Class 2 Device Recall ev3 Primus GPS Biliary Stent and Delivery System see related information
Date Initiated by Firm March 08, 2006
Date Posted May 31, 2006
Recall Status1 Terminated 3 on February 03, 2007
Recall Number Z-0912-06
Recall Event ID 34884
510(K)Number K043243  
Product Classification Biliary Stent - Product Code FGE
Product ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.
Code Information Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		 A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
FDA Determined
Cause 2		 Other
Action ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.
Quantity in Commerce 29
Distribution Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV
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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