BEUDAMED
    FDA Recall Open, Classified

    Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

    Recall: Z-1640-2025 · Initiated March 14, 2025

    Recall

    Recall Number
    Z-1640-2025
    Event Number
    96482
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    ODE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 14, 2025
    Posted
    April 21, 2025
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

    Reason

    Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

    Action

    On March 14, 2025, Merit Medical issued a "Urgent Medical Device Recall Notice via E-Mail, followed by mail to affected consignees. Merit asked consignees to take the following actions: 1. Read and understand this communication and the updated IFU referenced in the attached poster. 2. There is no need to return product to Merit. 3. Post the attached poster on or near the affected products so users are aware of the updated IFU. 4. Discard the current IFU with the product at point of use. 5. Ensure that applicable personnel within your organization are made aware of this communication. 6. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 7. If you require paper IFUs, please contact [email protected]. 8. Please acknowledging you are aware of the information communicated and have completed the actions required of you. 9. If you require additional product training regarding the IFU updates, please contact your Merit Sales Representative to schedule.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.

    Quantity

    1655 units