BEUDAMED
    FDA Enforcement Class I Terminated

    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is 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. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

    Recall: Z-2155-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2155-2014
    Event ID
    68806
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiovascular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    May 23, 2014
    Classification Date
    August 14, 2014
    Termination Date
    October 1, 2014
    Address
    651 Campus Dr, N/A, Saint Paul, MN, 55112-3495, United States

    Description

    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is 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. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

    Reason

    CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.

    Code Info

    100573, 100575, 100674, 100676, 100678, 100680.

    Distribution

    Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.

    Quantity

    48