FDA recall Z-0290-2022

Medtronic Vascular, Inc. · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2021-10-15
Report date: 2021-12-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Santa Rosa, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2022