Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Reported: December 1, 2021 Initiated: October 15, 2021 #Z-0290-2022
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
Details
- Recalling Firm
- Medtronic Vascular, Inc.
- Units Affected
- 2 devices
- 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.
- Location
- Santa Rosa, CA
Frequently Asked Questions
What product was recalled? ▼
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE. Recalled by Medtronic Vascular, Inc.. Units affected: 2 devices.
Why was this product recalled? ▼
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0290-2022.
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