BEUDAMED
    FDA Enforcement Class II Ongoing

    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

    Recall: Z-0808-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0808-2025
    Event ID
    95832
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aerin Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 15, 2025
    Initiation Date
    November 12, 2024
    Classification Date
    January 6, 2025
    Address
    232 E Caribbean Dr, Sunnyvale, CA, 94089-1007, United States

    Description

    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

    Reason

    Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.

    Code Info

    Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235

    Distribution

    US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV.

    Quantity

    479 units