Endologix’s AFX Endovascular AAA System has been recalled due to reports of certain endoleaks—Type llla and lllb endoleaks, which can lead to an abdominal aortic aneurysm rupture or death. The Class I recall affects 61,300 devices that were manufactured between March 2011 and present time. As noted on FDA’s website, most of the endoleaks have occurred with the AFX with Strata graft material. However: “Endologix has not manufactured the AFX with Strata graft material since July 2014 and health care providers were advised to remove any remaining inventory from shelves in December 2016. However, the AFX with Duraply graft material and AFX2 devices have been distributed for a shorter time and it is unclear if these devices have fewer endoleaks or if they have not been implanted long enough for endoleaks to occur,” states FDA.
In July Endologix sent an urgent letter to physicians about the issues with its AAA system and also made recommendations on patient surveillance, sizing and catheter-based interventions. Doctors were also told to continue “regular, lifelong” follow-up of any patients who have the Endologix AFX Endovascular AAA graft.