FDA-Device2021-12-01Class II
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medtronic Vascular, Inc.
Hazard
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Affected count
2 devices
Manufactured in
3850 Brickway Blvd, Santa Rosa, CA, United States
Products
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2022Don't want to check this manually?
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