99 results
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32ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430
FDA Recall
Terminated
·Datascope Corp·Product code DSP·November 19, 2007
Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ
FDA Recall
Terminated
·Datascope Corporation·Product code MHX·October 9, 2007
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·April 4, 2023
CS 100 Intra-Aortic Balloon Pump
FDA Recall
Terminated
·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 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 Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·May 4, 2023
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSP·March 27, 2012
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Recall
Open, Classified
·Datascope Corporation·Product code DSP·August 5, 2022
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Recall
Open, Classified
·Datascope Corporation·Product code DSP·August 5, 2022
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
FDA Recall
Open, Classified
·Datascope Corporation·Product code DSP·August 5, 2022
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 Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-UC-0800-65.
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·November 15, 2021
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0296-03 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0296-09 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0296-10 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0296-01U MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0296-02U MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) D684-00-0498-01 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) D684-00-0498-07 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0498-08 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB D884-00-0019-17
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·June 23, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·July 31, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·February 7, 2023
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·September 17, 2024
Battery Charging Station; Model: 0998-00-0802;
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·February 6, 2026
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
FDA Recall
Terminated
·Datascope Corp·Product code DRT·June 16, 2005
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·February 28, 2023