Date Initiated by Firm |
November 08, 2006 |
Date Posted |
December 27, 2006 |
Recall Status1 |
Terminated 3 on November 04, 2011 |
Recall Number |
Z-0310-2007 |
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 28-16-155BL |
Code Information |
Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501, W06-0658, W06-0773, W06-0988 & W06-1196 |
Recalling Firm/ Manufacturer |
Endologix Inc 11 Studebaker Irvine CA 92618-2013
|
For Additional Information Contact |
Janet 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 |
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 |
19 |
Distribution |
Worldwide, including USA and Germany. |
Total Product Life Cycle |
TPLC Device Report
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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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