BEUDAMED
    FDA Enforcement Class II Ongoing

    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology.

    Recall: Z-0104-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0104-2025
    Event ID
    95331
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    September 5, 2024
    Classification Date
    October 16, 2024
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565, United States

    Description

    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology.

    Reason

    Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.

    Code Info

    Material Number H7492493320C0, GTIN/UDI/DI 00191506033309, Batch/Serial Numbers: 103189853, 103416434, 103416437, 103416600, 103416629, 103416630, 103416690, 103469208, 103552000, 103552353, 103645606, 103645607, 103667250, 103710560, 103711075, 103799547, 104033389, 104035234, 104042507, 104112099, 104112181, 104113877, 104119696, 104124626, 104124634, 104125281, 104125291, 104185271, 104185745, 104196585, 104210922, 104212968, 104338136, 104340593, 104523528, 104535237, 104535289, 104548777, 104573317, 104586006, 104586008, 104586060, 104596504, 104597121, 104597142, 104877669, 104884458, 104889669, 104890938, 104890985, 104902736, 105072735, 105092091, 105092230, 105092231, 105471081, 105491421, 105542133

    Distribution

    US Nationwide distribution in Puerto Rico.

    Quantity

    58 units