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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 Treatmentsee related information
Date Initiated by FirmNovember 08, 2006
Date PostedDecember 27, 2006
Recall Status1 Terminated 3 on November 04, 2011
Recall NumberZ-0309-2007
Recall Event ID 36803
PMA NumberP040042 
Product Classification endovascular graft - Product Code MIH
ProductEndologix 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
FEI Number 1000125107
Recalling Firm/
Manufacturer		 Endologix Inc
11 Studebaker
Irvine CA 92618-2013
For Additional Information ContactJanet M. Fauls
949-595-7203
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		Other
ActionThe 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 Commerce11
DistributionWorldwide, including USA and Germany.
Total Product Life CycleTPLC 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.
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