FDA Communications

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

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

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 Communications

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

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

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