FDA: Endologix recall of AFX stent graft is Class I

Endologix (NSDQ:ELGX) said late last week that the FDA classified its voluntary recall of AFX Endovascular abdominal aortic aneurysm stent graft systems as Class I. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Irvine, Calif.-based company said it issued its recall action in July, sending safety notices to healthcare professionals who use the system. The notice included updated information on comparative Type III endoleak rates associated with the device, as well as patient surveillance recommendations and intervention recommendations. Type III endoleaks result from defects or mis-alignment of the stent graft components, allowing pressure to build in the aneurysm sac and increasing the risk of rupture. Last September the federal safety watchdog warned physicians about the risk of endoleaks with stent grafts used to wall off aneurysms in the abdominal aorta. Endologix said that the safety notice followed earlier communications, issued in late 2016 and early 2017, requesting the return of all AFX Strata stent graft devices, which had not been manufactured since 2018. “As outlined at our investor day on October 2, 2018, the AFX Strata product was removed from global inventory in the first half of 2017. Our current commercially available versions of the AFX system, the AFX Duraply and AFX2 products, are manufa...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Recalls Regulatory/Compliance Vascular Endologix Source Type: news