BEUDAMED
    FDA Recall Terminated

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360 and STEALTH Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems 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 systems are percutaneous orbital atherectomy systems indicated as therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. Coronary: The DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions

    Recall: Z-3021-2018 · Initiated April 13, 2018

    Recall

    Recall Number
    Z-3021-2018
    Event Number
    80765
    Firm
    Cardiovascular Systems Inc
    FEI Number
    3004742232
    Product Code
    MCX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 13, 2018
    Terminated
    November 4, 2019
    Address
    1225 Old Highway 8 NW, Saint Paul, MN, 55112-6416

    Description

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360 and STEALTH Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems 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 systems are percutaneous orbital atherectomy systems indicated as therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. Coronary: The DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions

    Reason

    The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.

    Action

    Consignees were sent a CSI "Urgent Medical Device Recall" letter dated 13 APRIL 2018. The letter listed the Affected Product, Recall Description, SIP Replacement and Return & contact information. Consignees were notified the pumps will be replaced. Consignees may continue to use their pumps however if a yellow light fault is observed and the troubleshooting per the IFU does not resolve the fault, discontinue use of the pump and notify CSI.

    Distribution

    US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX

    Quantity

    18