Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Recalled by Medtronic Vascular, Inc. Due to During product complaint investigation, it was determined that...
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 Medtronic Vascular, Inc. directly.
Affected Products
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
Quantity: 21 devices
Why Was This Recalled?
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Where Was This Sold?
This product was distributed to 8 states: GA, MD, MA, NY, SC, TX, WA, WV
About Medtronic Vascular, Inc.
Medtronic Vascular, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report