Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AFX Endovascular AAA System Recalled by Endologix Due to Endologix updated the Instructions for Use (IFU) and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Endologix directly.
Affected Products
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Quantity: 4,143 devices
Why Was This Recalled?
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Endologix
Endologix has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report