BEUDAMED
    FDA Enforcement Class II Ongoing

    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15

    Recall: Z-1939-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1939-2026
    Event ID
    98649
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diversatek Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2026
    Initiation Date
    March 18, 2026
    Classification Date
    April 23, 2026
    Address
    102 E Keefe Ave, N/A, Milwaukee, WI, 53212-1535, United States

    Description

    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15

    Reason

    The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

    Code Info

    UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629

    Distribution

    US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium

    Quantity

    527 units