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Medtronic Vascular, Inc. recalls Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49
Recalled August 4, 2021 · FDA recall Z-2135-2021 · Medtronic Vascular
Hazard
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover. · FDA Class II
Units
18 devices
Sold at
U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.
Description
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Product
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.
Manufacturer(s)
Medtronic Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →