BEUDAMED
    FDA Enforcement Class II Ongoing

    ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

    Recall: Z-1979-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-1979-2024
    Event ID
    94614
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2024
    Initiation Date
    May 3, 2024
    Classification Date
    June 4, 2024
    Address
    40 Continental Blvd, N/A, Merrimack, NH, 03054-4332, United States

    Description

    ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

    Reason

    Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

    Code Info

    Product Code: 22187; UDI-DI: 00650862221879.

    Distribution

    Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.

    Quantity

    53,308 units (US: 11, 236; OUS: 42,072)