BEUDAMED
    FDA Enforcement Class II Terminated

    DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

    Recall: Z-2385-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2385-2021
    Event ID
    88388
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiovascular Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    July 21, 2021
    Classification Date
    August 28, 2021
    Termination Date
    March 18, 2026
    Address
    1225 Old Highway 8 NW, N/A, Saint Paul, MN, 55112-6416, United States

    Description

    DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

    Reason

    There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.

    Code Info

    Lot 340925

    Distribution

    US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL

    Quantity

    8 units