BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

    Recall: Z-0210-2022 · Reported November 17, 2021

    Enforcement

    Recall Number
    Z-0210-2022
    Event ID
    88817
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 17, 2021
    Initiation Date
    September 29, 2021
    Classification Date
    November 5, 2021
    Termination Date
    February 13, 2025
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

    Reason

    The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.

    Code Info

    Lot 516840

    Distribution

    No domestic distribution. Foreign distribution to Hong Kong and UK.

    Quantity

    14 units