BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

    Recall: Z-0205-2015 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0205-2015
    Event ID
    69488
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 19, 2014
    Initiation Date
    October 13, 2014
    Classification Date
    November 13, 2014
    Termination Date
    February 18, 2015
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923-2565, United States

    Description

    Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

    Reason

    Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the

    Code Info

    Lot Number: 0007244836 MODEL: LA6JR40K

    Distribution

    US Distribution including the states of NC, IA, IL and KS.

    Quantity

    11 devices