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U.S. Department of Health and Human Services

Class 2 Device Recall Primus GPS Biliary Stent System

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  Class 2 Device Recall Primus GPS Biliary Stent System see related information
Date Initiated by Firm August 01, 2005
Date Posted January 25, 2006
Recall Status1 Terminated 3 on December 31, 2006
Recall Number Z-0442-06
Recall Event ID 34352
510(K)Number K043243  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
Code Information Lot no. 923291, 923290
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		 A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.
FDA Determined
Cause 2		 Other
Action Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.
Quantity in Commerce 18 devices
Distribution AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX
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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