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Medtronic Vascular, Inc. Recall 88951

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

Medtronic Vascular, Inc. Recall 88951 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0290-2022
Event ID88951
Event DescriptionEndurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Product TypeDevices
DistributionWorldwide 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.
Quantity2 devices
Recall ReasonDuring stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Device Classification20211201
Device Code InfoModel Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
Center Classification Date20211124
Recall Initiation Date20211015
Recalling FirmMedtronic Vascular, Inc.
Initial Notification Letter
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