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# FDA Updates Alert on Endovascular Graft Systems
- URL: https://www.fdaweb.com/fda-updates-alert-on-endovascular-graft-systems/
- Published: 2018-06-19T12:00:00.000Z
- Updated: 2026-09-15T00:14:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141718

FDA [says](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm611039.htm?ref=fdaweb.com) it continues to evaluate information from several sources, including endovascular graft system manufacturers, about the risks associated with Type III endoleaks with various aortic endovascular graft systems indicated for treating abdominal aortic aneurysms and aorto-iliac aneurysms. In 9/2017, an FDA [letter](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm577859.htm?ref=fdaweb.com) to health care providers alerted them about an increase in the occurrence of Type III endoleaks with the use of these devices for aneurysm repair. Since that alert and based on new information, the increased risk for Type III endoleak appears to be specific to one device at this time — the Endologix AFX with Strata device.

FDA says Endologix has not manufactured the graft material since July 2014, and in [December 2016](https://endologix.com/wp-content/uploads/2016/12/12-30-Physician-Letter-AFX-TIII-Endoleak-FINAL.pdf?ref=fdaweb.com) it requested that all AFX with Strata devices be removed from hospital inventory. Because there are patients that have previously been implanted with the device, the agency is recommending that physicians closely monitor patients who have the AFX with Strata device, and ensure annual follow-up at a minimum to monitor for Type III endoleaks.