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# Class 1 Recall for Endologicx Endovascular AAA Device
- URL: https://www.fdaweb.com/class-1-recall-for-endologicx-endovascular-aaa-device/
- Published: 2018-10-15T12:00:00.000Z
- Updated: 2026-09-15T00:38:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142582

FDA has [classified as a Class 1 recall ](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm623439.htm?ref=fdaweb.com)an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA \[abdominal aortic aneurysm\] System and the risks associated with Type III endoleaks. The device is indicated for treating abdominal aortic aneurysms. When a Type III endoleak occurs, blood continues to flow into the aneurysm, increasing the likelihood of a rupture, the agency says. Left undetected and without treatment, a Type III endoleak may result in serious patient injury, such as an AAA rupture or death, it adds.

  
The 7/20 safety notice provided updated information on comparative AFX Type III endoleak rates, patient-tailored surveillance recommendations, and recommendations for intervening through an AFX device or re-intervening on an AFX device, according to the company. No product was removed from the field as part of this recall, it says. 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 has not manufactured the device since 2014.