BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1988-2024 · Initiated May 3, 2024

    Recall

    Recall Number
    Z-1988-2024
    Event Number
    94614
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    DSY
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    May 3, 2024
    Posted
    June 4, 2024
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332

    Description

    ADVANTA VXT, 8X70, 1GDS, FH, 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.

    Action

    Consignees were sent an URGENT MEDICAL DEVICE- REMOVAL notification by mail, dated 5/3/24. Consignees are instructed to examine their inventory immediately to determine if any recalled product is in their possession. Recalled product possesses the REF number on device labeling and has an expiration date prior to 24FEB2027. All consignees are asked to complete and return the provided response form by email to [email protected] or by fax to 1-866-560-4062. Consignees that are distributors are asked to forward the provided notification to their customers. Consignees are to post a copy of the recall notification in all inventory locations where affected devices are stored and ensure all appropriate personnel are aware. If consignees possess recalled devices, they are to contact their local Atrium/Getinge Customer Support Department at 888-943-8872 (option 2) to receive instructions for returning any affected devices. The recalling firm will provide replacement product within 5-8 weeks of return of devices. The recalling firm states that if there is a medical need to use the device and no alterative device is available, then the graft may be used per the provided instructions. Customers can contact Customer support with any questions at 888-943-8872 (option 2) from Monday through Friday, between 8:00 AM and 6:00 PM.

    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)