BEUDAMED
    FDA Recall Terminated

    Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079

    Recall: Z-2299-2020 · Initiated March 23, 2020

    Recall

    Recall Number
    Z-2299-2020
    Event Number
    85424
    FEI Number
    3011525976
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    March 23, 2020
    Terminated
    August 13, 2021
    Address
    INARI MEDICAL 9 Parker, Ste 100, Irvine, CA, 92618-1666

    Description

    Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079

    Reason

    The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.

    Action

    On 03/23/20, Urgent Medical Device Recall notices were emailed to customers. Customers were asked to take the following actions: 1.Immediately review your inventory for the affected devices and quarantined to prevent their use. 2.Complete and return the Customer Response Form. 3.Return quarantined devices to recalling firm. 4.Report any adverse health consequences experienced with the use of this product to the recalling firm. Customers with additional questions were encouraged to contact the firm at: 877.923.4747 or [email protected] Additional recall notices with an expanded scope, dated 03/26/20, were also sent to additional customers.

    Distribution

    U.S Distribution in the states of .: IA, GA, MO, MI, AZ, FL, NJ, MN, LA, PA, AL, OH, NY, WI, CA, TX, TN, NH, IL, NC, CT, CO, OK, OR, IN, MA, VA, KY, WA, MS, SC, UT, SD, ND, AR, ID, DE, including DC.

    Quantity

    318