Class 2 Device Recall Protege GPS Biliary Stent System

• Date Initiated by Firm: June 10, 2005
• Date Posted: June 25, 2005
• Recall Status: Terminated on November 17, 2005
• Recall Number: Z-0936-05
• Recall Event ID: 32459
• 510(K)Number: K033314
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-10-30-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
• Code Information: 1179173
• Recalling Firm/ Manufacturer: Ev3; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: Michael D. Geary; 763-398-7546
• Manufacturer Reason for Recall: A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
• FDA Determined Cause: Other
• Action: ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.
• Quantity in Commerce: 1
• Distribution: FL and PA
• 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