BEUDAMED
    FDA Enforcement Class II Ongoing

    Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

    Recall: Z-2172-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2172-2026
    Event ID
    98633
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 20, 2026
    Initiation Date
    March 27, 2026
    Classification Date
    May 13, 2026
    Address
    1 Edwards Way, Irvine, CA, 92614-5688, United States

    Description

    Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

    Reason

    Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

    Code Info

    All Lots/UDI:0690103D004EVD000V5

    Distribution

    Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.