BEUDAMED
    FDA Recall Terminated

    FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.

    Recall: Z-0223-2016 · Initiated October 19, 2015

    Recall

    Recall Number
    Z-0223-2016
    Event Number
    72459
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 19, 2015
    Posted
    November 5, 2015
    Terminated
    April 12, 2016
    Address
    1625 W 3rd St, Tempe, AZ, 85281-2438

    Description

    FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.

    Reason

    Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.

    Action

    Bard sent an Urgent Medical Device Recall Notification letter dated October 19, 2015, to customers who received the Bard Flair Endovascular Stent Grant. The letter informs customers that the harm associated with failure to deploy or deployment related issues that could occur during use may pose an incremental risk to the already inherit risk associated with stent graft procedures. The letter also provides customers with the actions to be taken. Customers were instructed to call Bard Peripheral Vascular's (BPV) Recall Coordinator at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST). Customers were instructed to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.

    Distribution

    Nationwide in US

    Quantity

    292 units