Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Recalled by Medtronic Vascular, Inc. Due to During stent graft deployment, the radiopaque (RO) marker...

Date: June 7, 2021
Company: Medtronic Vascular, Inc.
Status: Ongoing
Source: FDA (Device)

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

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

Quantity: 18 devices

Why Was This Recalled?

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

Affected (8 states)Not affected

About Medtronic Vascular, Inc.

Medtronic Vascular, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report