BEUDAMED
    FDA Recall Open, Classified

    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2

    Recall: Z-0559-2018 · Initiated August 7, 2017

    Recall

    Recall Number
    Z-0559-2018
    Event Number
    79075
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    NEY
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 7, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2

    Reason

    The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

    Action

    All consignees were notified via Federal Express or certified mail on August 7, 2017, and the letter informs customers of the possible trocar tip disengagement and the actions they should take. Customers are requested to segregate and return affected product and acknowledge receipt and understanding of the Urgent Medical Device Recall Notice.

    Distribution

    Nationwide including PR, Canada, China