FDA Communications
News/Updates from the U.S. Food and Drug Administration
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 are publicly available online 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
