BEUDAMED
    FDA Enforcement Class II Terminated

    Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

    Recall: Z-0506-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0506-2018
    Event ID
    78897
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiovascular Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    September 14, 2017
    Classification Date
    February 2, 2018
    Termination Date
    November 4, 2019
    Address
    1225 Old Highway 8 NW, N/A, Saint Paul, MN, 55112-6416, United States

    Description

    Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

    Reason

    Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.

    Code Info

    Lot # 190217 Part #: 7-10011 Model # DBP-150SOLID145

    Distribution

    FL, IL, MI, MN, MO, NY, SC, TX, and WI

    Quantity

    8