Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 Recalled by Endologix Due to Endologix updated information on the rates of Type...
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
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-40 F00820-43 BEA25-110/I20-30 F00820-44 BEA25-90/I20-30 F00820-45 BEA25-70/I20-30 F00820-57 BEA22-80/I20-40 F00820-71 BEA22-90/I20-30 F00820-72 BEA22-70/I20-30 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Quantity: 832 units
Why Was This Recalled?
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
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