BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0210-2022 · Initiated September 29, 2021

    Recall

    Recall Number
    Z-0210-2022
    Event Number
    88817
    Firm
    Covidien Llc
    FEI Number
    1282497
    Product Code
    NEY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 29, 2021
    Terminated
    February 13, 2025
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    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.

    Action

    Beginning September 29, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to immediately quarantine and discontinue use of the affected products. Customers should return affected product to the firm. If product has been further distributed, please forward the recall information. Customers should complete and return the accompanying response form even if they do not have product on hand.

    Distribution

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

    Quantity

    14 units