FDA-Device2021-08-04Class II
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.
Medtronic Vascular, Inc.
Hazard
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Sold states
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.
Affected count
18 devices
Manufactured in
3850 Brickway Blvd, N/A, Santa Rosa, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2021Don't want to check this manually?
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