BEUDAMED
    FDA Recall 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 · Initiated August 15, 2014

    Recall

    Recall Number
    Z-2623-2014
    Event Number
    69089
    Firm
    Medtronic Cardiovascular Surgery-the Heart Valve Division
    FEI Number
    2025587
    Product Code
    DYE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 15, 2014
    Posted
    September 11, 2014
    Terminated
    November 6, 2014
    Address
    1851 E Deere Ave, Santa Ana, CA, 92705-5720

    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.

    Action

    An Urgent Medical Device Recall letter, dated August, 2014, was sent to customers on 8/15/14 for specific serial numbers of Hancock Apical Left Ventricle Connector, model H174Axx, devices. This recall is the result of a decision by Medtronic to discontinue sales of this low volume product, in lieu of fulfilling new regulatory requirements to maintain its distribution in the United States. Customers are instructed to quarantine and return all listed product in their inventory to Medtronic and contact customer service at (800) 854-3570. Customers are instructed to complete the attached customer confirmation certificate and e-mail it to [email protected] or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.

    Distribution

    Distributed in the states of MD and TX.

    Quantity

    2 units