BEUDAMED
    FDA Recall Open, Classified

    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.

    Recall: Z-0533-2026 · Initiated August 4, 2025

    Recall

    Recall Number
    Z-0533-2026
    Event Number
    97446
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DTL
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    August 4, 2025
    Posted
    November 17, 2025
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.

    Reason

    Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

    Action

    On 8/4/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Identify affected devices, quarantine, discontinue use, and distribution. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. Additional distribution details may be required by health authorities. 4) Complete and return the customer response form via email to [email protected] 5. Return all affected lots to Merit, per the instructions in the customer response form. If you have any questions concerning this communication, please contact the firm at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.

    Distribution

    US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND. OUS: United Arab Emirates, Australia, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Netherlands, Thailand, New Zealand, Mexico, Puerto Rico, Canada, Korea, Republic of, South Africa, Qatar, Iceland, United Kingdom, Viet Nam, Slovakia, Guam, Oman, Portugal, Madagascar, Saudi Arabia, Finland, Cyprus, Switzerland, Taiwan, China, Japan

    Quantity

    217,141