BEUDAMED
    FDA Recall Open, Classified

    GORE CARDIOFORM ASD Occluder. cardiovascular implant.

    Recall: Z-0136-2023 · Initiated September 21, 2022

    Recall

    Recall Number
    Z-0136-2023
    Event Number
    90912
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    MLV
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    September 21, 2022
    Posted
    October 26, 2022
    Address
    3750 W Kiltie Ln, Flagstaff, AZ, 86005-8712

    Description

    GORE CARDIOFORM ASD Occluder. cardiovascular implant.

    Reason

    Due to manufacturing records (Release Test Results) indicating "Failed".

    Action

    Between 09/21-32/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL/FIELD SAFETY NOTICE" via FedEx 2nd Day (U.S.), Postal Mail (EMEA), and Personal Delivery (Japan), informing customers that W.L. Gore & Associates (Gore) identified devices that were incorrectly released following a documented failure of a subset of quality tests. A failure of the subset of quality tests could potentially result in increased risks during the release of the device from the delivery system for the affected devices. Customer are instructed to: Identify and return any unused devices within the scope of this recall. Complete and sign the enclosed CUSTOMER RESPONSE FORM and return to [email protected] within 2 weeks of receipt of this notification. Share this letter with others in their institution as appropriate. Transfer this notice to other organization(s) as appropriate. If a listed device has been used, there is no patient follow-up needed and no further actions required other than informing Gore the device was used. Indicate the used device(s) on the CUSTOMER RESPONSE FORM and return to [email protected]. For questions, contact Gore Customer Service via email - [email protected]

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.

    Quantity

    98 units