BEUDAMED
    FDA Enforcement Class II Terminated

    LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

    Recall: Z-1498-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1498-2020
    Event ID
    85098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    February 24, 2020
    Classification Date
    March 13, 2020
    Termination Date
    August 4, 2022
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503, United States

    Description

    LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

    Reason

    The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.

    Code Info

    Device Listing: E572259 Product Code Product Description Affected Serial Number range 16-02-80 Heater-Cooler 3T, 230V 16S10027 16S16874 16-02-81 Heater-Cooler 3T, 240V 16S10743 16S11708 16-02-82 Heater-Cooler 3T, 208V 16S10772 16S16840 16-02-83 Heater-Cooler 3T, 127V 16S11455 16S16509 16-02-85 Heater-Cooler 3T, 120V 16S10958 16S16847 16-02-95 Heater-Cooler 3T, 200V 16S12004 16S16818

    Distribution

    U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none

    Quantity

    Total Worldwide=9309 systems (2713 system in U.S.)