BEUDAMED
    FDA Enforcement Class II Terminated

    Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

    Recall: Z-1203-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1203-2019
    Event ID
    82458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thoratec Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 1, 2019
    Initiation Date
    March 1, 2019
    Classification Date
    April 19, 2019
    Termination Date
    August 10, 2022
    Address
    6035 Stoneridge Dr, N/A, Pleasanton, CA, 94588-3270, United States

    Description

    Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

    Reason

    Small black plastic particle was observed in the left ventricle during implant procedure.

    Code Info

    Lot Numbers: 6675594 6675724 6675730 6677921 6696569 6696580 6696582 6696597 6696601 6696604 6703553 6703561 6703563 6703567 6721603 6721660 6721661 6721663 6721671 6721672 6721673 193496 193497 193499 193501 6425740 6425773 6449684 6675597 6449680 6425751 6425758 6425763 6425768 6449657 6449662 6512124 6677922 6425756 6425766 6425770 6449675 6449681 6449691 6675592 6677919 6677926 6694918 6696574 193500 193502 6425745 6425776 6449663 6449664 6449679 6449682 6449687 6449689 6677924 6677927 6692906 6693957 6696589 193495 193498 6449692 6675591 6675596 6692904 6696599 6512126 6675732 6675734 6675736 6692897 6449677 6692877

    Distribution

    US Nationwide distribution in the states of MN, WI, TX, NC, GA, OK, UT, NY, SC, IL, LA, MI, IN, CA, OH, WA. Foreign (OUS): AUSTRIA, BELGIUM, CANADA, ESTONIA, FRANCE, GERMANY, GREECE, INDIA, ITALY, KUWAIT, LIECHTENSTEIN, LITHUANIA, NETHERLANDS, POLAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TURKEY, UNITED KINGDOM

    Quantity

    650