FDA Communications

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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

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March 9, 2022

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

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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

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January 24, 2022

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

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January 13, 2022

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

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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

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May 26, 2021

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

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Mar. 31, 2021

FDA Upcoming Meeting Notice

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Dec. 29, 2020

FDA designates recalls of two vascular catheters as Class I

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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

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Dec. 9, 2020

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