BEUDAMED
    FDA Recall Open, Classified

    Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET

    Recall: Z-0291-2022 · Initiated October 15, 2021

    Recall

    Recall Number
    Z-0291-2022
    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 II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET

    Reason

    Due to, 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

    511 devices