BEUDAMED
    FDA Recall 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 · Initiated March 1, 2019

    Recall

    Recall Number
    Z-1203-2019
    Event Number
    82458
    Firm
    Thoratec Corp.
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 1, 2019
    Posted
    April 19, 2019
    Terminated
    August 10, 2022
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    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.

    Action

    On 03/01/19, sales representatives started visiting and telephoning consignees informing them to quarantine affected devices. The firm requested that consignees complete and return the Device Retrieval Template. On 03/08/19, Urgent Medical Device Recall notices were hand delivered to all impacted accounts. Customers were advised to stop use, quarantine, and return any units on hand. For patients, who's implant procedure included the use of affected devices, firm recommends close vigilance for potential harm, which could include concerns such as infection or thromboembolism. The coring knife is not impacted. Firm requests that customers complete and return the acknowledgement form. Firm recommends that customer with additional questions call 1-800-456-1477.

    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