Medtronic Vascular, Inc.: Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

Is my product affected?

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

• UPC 00763000006129

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Vascular is recalling two Endurant Stent Graft System devices (model ENTF2525C70EE) due to a potential defect where the spindle may detach from the distal end of the spindle hypotube during stent graft deployment. The affected devices have serial numbers V30624638 and V30624639, and were distributed worldwide including across multiple U.S. states and numerous countries in Europe, Asia, Africa, and the Middle East.

The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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, Quantity: 2 devices Lot/code info: Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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