BEUDAMED
    FDA Recall Open, Classified

    Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

    Recall: Z-2172-2026 · Initiated March 27, 2026

    Recall

    Recall Number
    Z-2172-2026
    Event Number
    98633
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    NPW
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    March 27, 2026
    Posted
    May 13, 2026
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    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.

    Action

    On March 27, 2025, Edwards Lifesciences issued a Urgent: Medical Device Recall (Correction) Notification via mail. Edwards ask consignees to take the following actions: 1. There is no need to return any product and no patient follow-up or notification is necessary. 2. Please review this Urgent: Medical Device Recall (Correction) Notice . 3. Return the completed Customer Acknowledgment Form to your Edwards TMTT Representative or via email to [email protected]. Electronic signatures may also be used, where available, to facilitate physician acknowledgment.

    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.