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U.S. Department of Health and Human Services

Class 2 Device Recall Protege GPS Biliary Stent System

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  Class 2 Device Recall Protege GPS Biliary Stent System see related information
Date Initiated by Firm September 01, 2004
Date Posted October 05, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-0008-05
Recall Event ID 29996
510(K)Number K033314  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product Biliary Stent System (6Fr 9mm x 30mm).
Code Information SERB65-09-30-120 (.035) (Biliary) LOT #: 257441
Recalling Firm/
Manufacturer		 Ev3
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		 A customer complaint received indicated that a Prot¿g¿ stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Prot¿g¿ GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.
FDA Determined
Cause 2		 Other
Action A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
Quantity in Commerce 5 systems
Distribution South Carolina, North Carolina, and Texas.
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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