BEUDAMED
    FDA Recall Open, Classified

    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

    Recall: Z-0077-2022 · Initiated September 7, 2021

    Recall

    Recall Number
    Z-0077-2022
    Event Number
    88721
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    PRL
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    September 7, 2021
    Address
    3750 W Kiltie Ln, Flagstaff, AZ, 86005-8712

    Description

    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

    Reason

    Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

    Action

    On September 9, 2021, Gore issued a "Urgent Field Safety Notice" to affected consignees via E-Mail. In addition to informing consignees about the recalled product, Gore asked consignees to take the following actions: 1. Identify and return the device listed in the CHANNEL PARTNER RESPONSE FORM if unused. 2. Please complete and sign the enclosed CHANNEL PARTNER RESPONSE FORM and return to [email protected] within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. 4. If a listed device has been implanted, there is no patient-follow up needed and there are no further actions needed other than informing Gore the device was used. Please indicate the used device on the CHANNEL PARTNER RESPONSE FORM and return to [email protected] within 2 weeks of receipt of this letter. No further action is needed. 5. Any adverse event involving the GORE VIABAHN VBX Balloon Expandable Endoprosthesis should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: [email protected] or contact: EMEA: +49 89 4612 3440, Fax: +49 89 4612 43440 6. This notice needs to be passed on to all those who need to be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). Please transfer this notice to other organization(s) on which this action has an impact (as appropriate).

    Distribution

    International distribution to the countries of Italy & Lebanon.

    Quantity

    2 units