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U.S. Department of Health and Human Services

Class 2 Device Recall System, Endovascular Graft Aortic Aneurysm Treatment

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  Class 2 Device Recall System, Endovascular Graft Aortic Aneurysm Treatment see related information
Date Initiated by Firm November 08, 2006
Date Posted December 27, 2006
Recall Status1 Terminated 3 on November 04, 2011
Recall Number Z-0309-2007
Recall Event ID 36803
PMA Number P040042 
Product Classification endovascular graft - Product Code MIH
Product Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL
Code Information Lot Numbers: W06-0333, W06-0392, W06-0500, W06-0553, W06-0621, W06-1100 & W06-1152
Recalling Firm/
Endologix Inc
11 Studebaker
Irvine CA 92618-2013
For Additional Information Contact Janet M. Fauls
Manufacturer Reason
for Recall
Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
FDA Determined
Cause 2
Action The affected hospitals were contacted telephone on 11/08/06 and in writing (Recall Letters) sent via FedEx 11/09/06. The firm also released a press statement on 11/10/06. All affected consignees have been contacted and instructed to return the specified products to Endologix.
Quantity in Commerce 11
Distribution Worldwide, including USA and Germany.
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.