14 results
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113ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
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 Enforcement
Class II
·Terminated·Maquet Datascope Corp - Cardiac Assist Division·March 8, 2017
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 Enforcement
Class I
·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·June 6, 2018
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 Enforcement
Class II
·Terminated·Maquet Datascope Corp - Cardiac Assist Division·February 18, 2015
Cardiosave Hybrid and rescue IABP
FDA Enforcement
Class II
·Terminated·Maquet Datascope Corp - Cardiac Assist Division·April 6, 2016
CS 300 Intra-Aortic Balloon Pump
FDA Enforcement
Class I
·Terminated·Maquet Datascope Corp - Cardiac Assist Division·August 2, 2017
CS 100 Intra-Aortic Balloon Pump
FDA Enforcement
Class I
·Terminated·Maquet Datascope Corp - Cardiac Assist Division·August 2, 2017
CS 100i Intra-Aortic Balloon Pump
FDA Enforcement
Class I
·Terminated·Maquet Datascope Corp - Cardiac Assist Division·August 2, 2017
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 Enforcement
Class I
·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·September 13, 2017
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 Enforcement
Class I
·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·September 13, 2017
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 Enforcement
Class I
·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·September 13, 2017
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
FDA Enforcement
Class I
·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·November 7, 2018
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
FDA Enforcement
Class I
·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·November 7, 2018