BEUDAMED
    FDA Enforcement Class I Terminated

    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    Recall: Z-1058-2016 · Reported March 16, 2016

    Enforcement

    Recall Number
    Z-1058-2016
    Event ID
    73266
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International, Inc., Division of Teleflex Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2016
    Initiation Date
    February 10, 2016
    Classification Date
    March 10, 2016
    Termination Date
    May 12, 2021
    Address
    9 Plymouth St, N/A, Everett, MA, 02149-1814, United States

    Description

    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    Reason

    The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

    Code Info

    Batch: 18F14B0044 18F14B0045 18F14E0060 18F14F0019 18F14G0067 18F14H0002 18F14J0026 18F15A0033 18F15B0009 18F15B0019 18F15C0012 18F15D0016 18F15D0037 18F15D0044 18F15F0001

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).

    Quantity

    13,405 US and 33,735 OUS in total