FDA Communications

News/Updates from the U.S. Food and Drug Administration (FDA)

December 6, 2022

Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication

September 12, 2022

FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers

March 9, 2022

Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use

March 1, 2022

FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers

January 24, 2022

The FDA has issued a Class 1 Device Recall for HawkOne – Please see the FDA’s Notice for Further Notification

January 13, 2022

FDA has issued an important Safety Communication Update on the Endologix AFX

October 29, 2021

Notice AAA Advisory Committee Meeting November 2-3, 2021

The Background Materials and live webcast link for the meeting are expected to be publicly available online by the end of Friday, October 29 via the following link:

https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2021-circulatory-system-devices-panel-medical-devices-advisory-committee-meeting

Day 1 Summary

Day 2 Summary

May 26, 2021

Update from Medtronic on the Voluntary Recall of their Valiant Navion Thoracic Stent Graft

Mar. 31, 2021

FDA Upcoming Meeting Notice

Dec. 29, 2020

FDA designates recalls of two vascular catheters as Class I

Dec. 17, 2020

Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers

Dec. 9, 2020

FDA Update: Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular Graft Systems