FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall

 

October 5, 2018—Endologix, Inc. announced that it has received notice that the FDA has classified a voluntary recall action that the company took in July 2018 as a class I recall. The July recall involved Endologix’s issuance of a safety notice to health care professionals (HCPs) using the company's AFX endovascular abdominal aortic aneurysm (AAA) system for endovascular aneurysm repair (EVAR).

The safety notice, dated July 20, 2018, provided updated information on comparative AFX type III endoleak rates, patient-tailored surveillance recommendations, and recommendations for intervening through an AFX device or reintervening on an AFX device. No product was removed from the field as part of this recall.

The July 2018 safety notice followed several earlier communications. Safety notices from Endologix issued in late 2016 and early 2017 requested that all remaining AFX Strata devices be returned from the field and emphasized that Endologix had not manufactured AFX Strata grafts since 2014.

On September 28, 2017, the FDA issued a letter to HCPs to raise awareness of an increased occurrence of type III endoleaks after EVAR.

On June 19, 2018, the FDA issued an updated letter to HCPs that indicated the increased risk for type III endoleak appears to be specific to one device at this time, the AFX with Strata device. In the announcement, the company advised that the AFX Strata product was removed from global inventory in the first half of 2017.

The company's current commercially available versions of the AFX system—the AFX Duraply and AFX2 products—are manufactured using a different expanded polytetrafluoroethylene processing methodology and include additional product improvements. These AFX Duraply and AFX2 products were part of the July 2018 safety notice providing updated recommendations to HCPs on how to reintervene on or through these products, but they were not the subject of the voluntary product removal actions in December 2016/January 2017.

Furthermore, AFX Duraply and AFX2 products were not the subject of the FDA's letter to HCPs from June 19, 2018. The use of the AFX Duraply and AFX2 systems for patients with AAA is supported by the company's comprehensive system of postmarket surveillance, anonymized registry data, and the randomized LEOPARD trial that compares EVAR systems, stated Endologix.

 

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