BEUDAMED
    FDA Enforcement Class II Terminated

    DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs 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. The Stealth 360 Orbital PAD 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.

    Recall: Z-1230-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1230-2017
    Event ID
    76352
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiovascular Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    December 7, 2016
    Classification Date
    February 22, 2017
    Termination Date
    March 23, 2017
    Address
    1225 Old Highway 8 NW, N/A, Saint Paul, MN, 55112-6416, United States

    Description

    DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs 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. The Stealth 360 Orbital PAD 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.

    Reason

    CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

    Code Info

    Lot: 171686, Expiration: 2018-09-30

    Distribution

    Nationwide Distribution to LA, MS, SC, TX

    Quantity

    8 units