BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J

    Recall: Z-0716-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0716-2020
    Event ID
    84399
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2019
    Initiation Date
    November 15, 2019
    Classification Date
    December 19, 2019
    Termination Date
    June 19, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J

    Reason

    Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death

    Code Info

    Lot Number: 16F19H0093

    Distribution

    U.S. Nationwide, Canada

    Quantity

    1 unit