BEUDAMED
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    DATASCOPE

    FDA Adverse Event
    Malfunction ·MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION·Product code DSP·June 6, 2014

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    FDA Adverse Event
    Malfunction ·MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION·Product code DSP·June 18, 2014

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    FDA Adverse Event
    Malfunction ·MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION·Product code DSP·June 12, 2015

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·January 30, 2015

    CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

    FDA Recall
    Open, Classified ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·July 17, 2017

    Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

    FDA Recall
    Open, Classified ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·September 20, 2018

    CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

    FDA Recall
    Open, Classified ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·July 17, 2017

    CS 100 Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    Cardiosave Hybrid and rescue IABP

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·December 16, 2015

    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·December 23, 2016

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·March 21, 2014

    CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

    FDA Recall
    Open, Classified ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·July 17, 2017

    CS 100i Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    CS 300 Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

    FDA Recall
    Open, Classified ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·September 20, 2018

    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179

    FDA Recall
    Open, Classified ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·May 3, 2018

    Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code FMZ·March 16, 2011

    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·December 16, 2014

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    FDA Enforcement
    Class I ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·May 28, 2014

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    FDA Enforcement
    Class II ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·March 4, 2015