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Recall Observatory FDA recall evidence

Device product

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

Z-0290-2022

October 15, 2021

Class II

Product summary

Firm
Medtronic Vascular, Inc.
Event
Event 88951
Status
Ongoing
Classification
Class II
Quantity
2 devices
Official record key
device-enforcement:Z-0290-2022

Official wording

Reason: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

Code information: Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube