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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 Systemsee related information
Date Initiated by FirmAugust 01, 2005
Date PostedJanuary 25, 2006
Recall Status1 Terminated 3 on December 31, 2006
Recall NumberZ-0442-06
Recall Event ID 34352
510(K)NumberK043243 
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
ProductPrimus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
Code Information Lot no. 923291, 923290
FEI Number 2183870
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
ActionNotification 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 Commerce18 devices
DistributionAL, AZ, FL, KS, LA, MS, NC, NE, NY, TX
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.
510(K) Database510(K)s with Product Code = FGE
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