BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0290-2022 · Initiated October 15, 2021

    Recall

    Recall Number
    Z-0290-2022
    Event Number
    88951
    Firm
    Medtronic Vascular, Inc.
    FEI Number
    3005364322
    Product Code
    MIH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 15, 2021
    Address
    3850 Brickway Blvd, Santa Rosa, CA, 95403-8223

    Description

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

    Reason

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

    Action

    On or about 10/15/2021, the firm initiated a global verbal notification to customers informing them that is the potential for a specific subset of 18Fr Stent Graft Systems to have the potential for the spindle to detach from the spindle hypotube during deployment. On 10/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery. Customers are instructed to take the following actions: 1) Return all unused affected devices to the Recalling Firm via their sales representative or calling customer service at 1-888-283-7868 or email [email protected]. 2) Complete the enclosed Customer Confirmation Form and email to [email protected]. 3) Forward this Recall notice to all those who need to be aware within their organization to include physician implanters (US only). Additionally, if any affected devices have been distributed to other organizations, forward this notice to those entities. For questions or assistance - contact their Field Representative or Customer Service at 888-283-7868 or email [email protected].

    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.

    Quantity

    2 devices