BEUDAMED
    FDA Enforcement Class II Terminated

    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.

    Recall: Z-2623-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2623-2014
    Event ID
    69089
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Cardiovascular Surgery-the Heart Valve Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    August 15, 2014
    Classification Date
    September 11, 2014
    Termination Date
    November 6, 2014
    Address
    1851 E Deere Ave, N/A, Santa Ana, CA, 92705-5720, United States

    Description

    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.

    Reason

    Medtronic has decided to discontinue production and distribution of this low-volume product.

    Code Info

    Serial Numbers: B146341, B146350

    Distribution

    Distributed in the states of MD and TX.

    Quantity

    2 units