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U.S. Department of Health and Human Services

Class 2 Device Recall AFX Endovascular AAA System, Endoleak Type IIIB

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  Class 2 Device Recall AFX Endovascular AAA System, Endoleak Type IIIB see related information
Date Initiated by Firm December 27, 2016
Date Posted January 18, 2017
Recall Status1 Terminated 3 on April 28, 2017
Recall Number Z-1038-2017
Recall Event ID 76110
PMA Number P040002 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product AFX Endovascular AAA System, Endoleak Type IIIB;
The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Code Information The correction is not lot specific. It applies to AFX procedures conducted after July 2015
Recalling Firm/
Manufacturer		 Endologix
35 Hammond
Irvine CA 92618-1607
Manufacturer Reason
for Recall		 Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
FDA Determined
Cause 2		 Other
Action A Dear Physician letter dated 6/2/15 was sent to customers to inform them that the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provides update reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). On January 2016, a Dear Physician letter was sent to customers to inform them of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The letter provided update reports on the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of these devices. A Dear Physician letter dated 12/27/16 will be sent to inform customers of the important information related to the AFX Endovascular AAA System (AFX System). The letter provides a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented, including introduction of a graft material processing improvement known as Duraply. Customers with any questions are instructed to contact their Endologix representative.
Quantity in Commerce 40967
Distribution US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
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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