Class 2 Device Recall POWERLINK SYSTEM DELIVERY CATHETER

• Date Initiated by Firm: December 14, 2005
• Date Posted: March 22, 2006
• Recall Status: Terminated on March 22, 2012
• Recall Number: Z-0589-06
• Recall Event ID: 34219
• PMA Number: P040002
• Product Classification: System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
• Product: Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Code Information: Lot # W05-0884
• FEI Number: 1000125107
• Recalling Firm/ Manufacturer: Endologix Inc; 13900 Alton Pkwy Ste 122; Irvine CA 92618-1621
• For Additional Information Contact: Janet Fauls; 949-595-7203
• Manufacturer Reason for Recall: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
• FDA Determined Cause: Other
• Action: The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05. Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05.
• Quantity in Commerce: 9 (8 already used and 1 currently in distribution)
• Distribution: For units still in distribution: AZ, DE, KS, PA, & TN
• 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.

• PMA Database: PMAs with Product Code = MIH