Endologix Broadens Recall to All AFX Endovascular AAA Systems

Patrice Wendling

October 16, 2018

Endologix is recalling all of its AFX endovascular abdominal aortic aneurysm (AAA) systems after continued reports of type III endoleaks.

The US Food and Drug Administration (FDA) has identified this as a class I recall, the most serious type of recall, and cautions that "left undetected and untreated, type III endoleaks may result in serious patient injury, such as an AAA rupture or death."

As recently reported, the FDA issued a safety alert to healthcare professionals in July warning that the AFX system with Strata graft material is associated with a greater risk for type III endoleaks than other AAA repair systems and advised providers to "ensure annual follow-up at a minimum to monitor for type III endoleaks."

Endologix has not manufactured the AFX system with Strata device since July 2014, and physicians were advised to pull any remaining inventory in December 2016.

"It is important to note that although this recall applies to all AFX Endovascular AAA Systems, most reports of endoleaks have concerned the AFX with Strata graft material," the agency writes in today's release. "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."

As part of the broader recall, Endologix is updating its December 2016 safety notification, notifying physicians of new patient surveillance recommendations, and providing general warnings about interventions to or through an existing AFX device.

No product return is required but physicians are advised to continue regular, lifelong follow-up of all patients treated with an Endologix AFX endovascular AAA graft.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.


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