Home / Recalls / Medtronic Vascular, Inc. / Z-0290-2022

Z-0290-2022 Class II Ongoing

Recalled by Medtronic Vascular, Inc. — Santa Rosa, CA

Recall Details

Product Type
Devices
Report Date
December 1, 2021
Initiation Date
October 15, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 devices

Product Description

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

Reason for Recall

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

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.

Code Information

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

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  • Z-0657-2022 Class II — Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant (December 21, 2021)
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  • Z-2135-2021 Class II — Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graf (June 7, 2021)
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  • Z-1976-2021 Class II — Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For (April 28, 2021)
  • Z-1201-2021 Class I — Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions (February 12, 2021)