BEUDAMED
    FDA Enforcement Class II Terminated

    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.

    Recall: Z-2256-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2256-2018
    Event ID
    80180
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PENTAX of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2018
    Initiation Date
    March 30, 2018
    Classification Date
    June 19, 2018
    Termination Date
    April 28, 2021
    Address
    303 Convention Way Ste 1, N/A, Redwood City, CA, 94063-1415, United States

    Description

    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.

    Reason

    The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.

    Code Info

    Lot Codes: 02132018-01 & 02162018-03

    Distribution

    Distribution US nationwide.

    Quantity

    57 units