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Maquet Datascope Corp - Cardiac Assist Division Recalls
14 recalls on record · May 28, 2014 to November 7, 2018 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 7, 2018Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Hazard: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
November 7, 2018Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Hazard: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
June 6, 2018Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-080
Hazard: Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
September 13, 2017Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducin
Hazard: False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
September 13, 2017Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducin
Hazard: False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
September 13, 2017Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reduci
Hazard: False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
August 2, 2017Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CS 300 Intra-Aortic Balloon Pump
Hazard: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
August 2, 2017Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CS 100 Intra-Aortic Balloon Pump
Hazard: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
August 2, 2017Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CS 100i Intra-Aortic Balloon Pump
Hazard: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
March 8, 2017Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected par
Hazard: Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
April 6, 2016Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls Cardiosave Hybrid and rescue IABP
Hazard: Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
March 4, 2015Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Hazard: Power supply malfunction complaints related to suboptimal thermal management.
February 18, 2015Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION
Hazard: Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.
May 28, 2014Medical DevicesFDA
Maquet Datascope Corp - Cardiac Assist Division recalls Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) i
Hazard: Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.