Class 2 Device Recall Protg GPS" Biliary Stent System

• Date Initiated by Firm: April 22, 2008
• Date Posted: August 26, 2008
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-2170-2008
• Recall Event ID: 48615
• 510(K)Number: K043243
• Product Classification: Biliary Catheter - Product Code FGE
• Product: Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use before 2009-02 Sterile EO Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 Intended as a palliative treatment of malignant neoplasms in the biliary tree.
• Code Information: Lot 2092998
• Recalling Firm/ Manufacturer: Ev3, Inc; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: 763-398-7000
• Manufacturer Reason for Recall: A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent.
• FDA Determined Cause: Employee error
• Action: The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
• Quantity in Commerce: 1 Unit
• Distribution: Nationwide Distribution --- state of NJ
• 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