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U.S. Department of Health and Human Services

Class 2 Device Recall AFX Endovascular AAA System

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  Class 2 Device Recall AFX Endovascular AAA System see related information
Date Initiated by Firm December 27, 2016
Date Posted January 19, 2017
Recall Status1 Terminated 3 on April 28, 2017
Recall Number Z-1047-2017
Recall Event ID 76112
PMA Number P040002 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product AFX Endovascular AAA System, Endoleak Type IIIA

Product Usage:
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 October 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		 Nonconforming Material/Component
Action On 6/2/15, a Dear Physician letter was sent to inform their customers of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update reports of 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 of 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. On 12/27/16, a Dear Physician letter will be sent to customers to inform them 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. Customer are informed of the on-going Endologix investigation that the changes may help prevent the occurrence of Type III endoleaks reported with the AFX device.
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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