Class I Recall of the AFX Endovascular AAA System

A voluntary recall of the AFX® Endovascular AAA System made in July of this year has been classified a Class I Recall by The Food and Drug Administration. A Class I recall is the most serious recall the FDA issues. It is only used when the product could cause serious health consequences or death.

The AFX® Endovascular AAA System is developed by Endologix Inc. It is manufactured to treat abdominal aortic aneurysms or AAA. Abdominal aortic aneurysms are the weakening of the wall of the aorta, the largest artery in the body.

The July 20th, 2018 safety notice warned of an increased risk of serious endoleaks caused by a discontinued stent graft that Endologix used to make. An endoleak occurs when blood leaks back into the aneurysm sac. At the time, the warning was released due to an increase in adverse event reports from physicians and medical device companies.

According to the FDA, “ Endologix has not manufactured the AFX with Strata graft material since July 2014, and in December 2016 requested that all AFX with Strata devices be removed from hospital inventory.”

Those who may have been treated with an AFX Endovascular AAA system, and believe they may be at risk, should speak to their doctor or healthcare professional.