Recall Z-2136-2021— Medtronic Vascular, Inc.

Name: FDA recall Z-2136-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-07

Class II · Ongoing

Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2021-06-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..

Recalling firm: Medtronic Vascular, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-06-07
Firm location: Santa Rosa, CA, United States

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.