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U.S. Department of Health and Human Services

Class 2 Device Recall POWERLINK SYSTEM DELIVERY CATHETER

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  Class 2 Device Recall POWERLINK SYSTEM DELIVERY CATHETER see related information
Date Initiated by Firm December 14, 2005
Date Posted March 22, 2006
Recall Status1 Terminated 3 on March 22, 2012
Recall Number Z-0594-06
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. 28-16-135BL
Code Information W05-0512 & W05-0912
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 2		 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 32 (24 already used and 8 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 and Original Applicant = Endologix, LLC
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