BEUDAMED
    FDA Enforcement Class I Terminated

    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15

    Recall: Z-2038-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2038-2017
    Event ID
    76841
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    March 22, 2017
    Classification Date
    May 12, 2017
    Termination Date
    February 7, 2018
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630, United States

    Description

    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15

    Reason

    Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

    Code Info

    Lot Number 61209G1 61209G2 61102G1 61102G1 61012G1 61209G1 61101G1 60415G1 61209G1 61102G1 61101G1 61101G1 61102G1 60415G1 61102G1 61101G1 60415G1 61209G1 61102G1 50415G1 50919G1 51110G1 61209G1 50919G1 51210G1 61101G1 61102G1 60415G1 61102G1 60415G1 61209G1

    Distribution

    US and Worldwide

    Quantity

    449,661 units total (132,040 units in US)