FDA-Device2022-03-02Class II
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE;
Medtronic Vascular, Inc.
Hazard
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay and Viet Nam.
Affected count
14,629 devices
Manufactured in
3850 Brickway Blvd, Santa Rosa, CA, United States
Products
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE; ENCF2323C45EE; ENCF2525C45EE; ENCF2828C45EE; ENCF3232C45EE; ENCF3636C45EE; ENTF2323C70EE; ENTF2525C70EE; ENTF2828C70EE; Medtronic Endurant II Stent Graft System Model/REF ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C145EJ; ETBF2313C166EE; ETBF2313C166EJ; ETBF2316C124E; ETBF2316C124EE; ETBF2316C124EJ; ETBF2316C145E; ETBF2316C145EE; ETBF2316C145EJ; ETBF2316C166E; ETBF2316C166EE; ETBF2316C166EJ; ETBF2513C124E; ETBF2513C124EE; ETBF2513C124EJ; ETBF2513C145EE; ETBF2513C145EJ; ETBF2513C166E; ETBF2513C166EE; ETBF2513C166EJ; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C145EJ; ETBF2516C166E; ETBF2516C166EE; ETBF2516C166EJ; ETBF2813C124EE; ETBF2813C124EJ; ETBF2813C145E; ETBF2813C145EE; ETBF2813C145EJ; ETBF2813C166E; ETBF2813C166EE; ETBF2813C166EJ; ETBF2816C124EE; ETBF2816C124EJ; ETBF2816C145E; ETBF2816C145EE; ETBF2816C145EJ; ETBF2816C166E; ETBF2816C166EE; ETBF2816C166EJ; ETBF2820C124EE; ETBF2820C145EE; ETBF2820C145EJ; ETBF2820C166E; ETBF2820C166EE; ETBF2820C166EJ; ETBF3216C124E; ETBF3216C124EE; ETBF3216C124EJ; ETBF3216C145E; ETBF3216C145EE; ETBF3216C145EJ; ETBF3216C166EE; ETBF3216C166EJ; ETBF3220C124EE; ETBF3220C145EE; ETBF3220C166E; ETBF3220C166EE; ETBF3220C166EJ; ETBF3616C145E; ETBF3616C145EE; ETBF3616C145EJ; ETBF3616C166E; ETBF3616C166EE; ETBF3616C166EJ; ETBF3620C145EE; ETBF3620C166EE; ETBF3620C166EJ; ETCF2323C49E; ETCF2323C49EE; ETCF2525C49E; ETCF2525C49EE; ETCF2525C49EJ; ETCF2828C49E; ETCF2828C49EE; ETCF2828C49EJ; ETCF3232C49E; ETCF3232C49EE; ETCF3232C49EJ; ETCF3636C49E; ETCF3636C49EE; ETCF3636C49EJ; ETTF2323C70E; ETTF2323C70EE; ETTF2323C70EJ; ETTF2525C70E; ETTF2525C70EE; ETTF2525C70EJ; ETTF2828C70E; ETTF2828C70EE; ETTF2828C70EJ; ETTF3232C70E; ETTF3232C70EE; ETTF3232C70EJ; ETTF3636C70E; ETTF3636C70EE; ETTF3636C70EJ; ETUF2314C102E; ETUF2314C102EE; ETUF2314C102EJ; ETUF2514C102E; ETUF2514C102EE; ETUF2514C102EJ; ETUF2814C102E; ETUF2814C102EE; ETUF2814C102EJ; ETUF3214C102E; ETUF3214C102EE; ETUF3614C102E; ETUF3614C102EE; Medtronic Endurant IIs Stent Graft System Model/REF: ESBF2314C103E; ESBF2314C103EE; ESBF2314C103EJ; ESBF2514C103E; ESBF2514C103EE; ESBF2514C103EJ; ESBF2814C103E; ESBF2814C103EE; ESBF2814C103EJ; ESBF3214C103E; ESBF3214C103EE; ESBF3214C103EJ; ESBF3614C103E; ESBF3614C103EE; ESBF3614C103EJ; 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-0657-2022Don't want to check this manually?
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