The voluntary recall of the AFX Endovascular AAA System made earlier this year has been classified a Class I Recall by The Food and Drug Administration.
The AFX Endovascular AAA System, 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 AFX® Endovascular AAA System is developed by Endologix Inc.
The July 20th 2018 safety notice warned of an increased risk of serious endoleaks caused by a discontinued stent graft that the company Endologix used to make. An endoleak occurs when blood leaks back into the aneurysm sac.
Class I Recall
At the time of the July safety notice, the warning was released due to an increase of adverse event reports from physicians and medical device companies. It is now a Class I Recall. 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 with Strata graft material has been removed from hospital inventory and has not been manufactured since 2014.
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.