Medtronic Vascular, Inc. recalls Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- Recall date
- October 15, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0290-2022
- FDA classification
- Class II
- Brand / firm
- Medtronic Vascular, Inc.
- Sold / distributed
- 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…
Why it was recalled
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
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