Class 2 Device Recall Protege GPS

• Date Initiated by Firm: July 09, 2004
• Date Posted: August 07, 2004
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-1329-04
• Recall Event ID: 29629
• 510(K)Number: K033314
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
• Code Information: Lot # 672655
• Recalling Firm/ Manufacturer: Ev3; 4600 Nathan Ln N; Plymouth MN 55442-2890
• Manufacturer Reason for Recall: Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018').
• FDA Determined Cause: Other
• Action: Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.
• Quantity in Commerce: 10
• Distribution: Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S.
• 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