22 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·December 22, 2021
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·January 25, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
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 Rescue. Model Number: 0998-00-0800-83.
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
FDA Enforcement
Class I
·Ongoing·Maquet Datascope Corp - Cardiac Assist Division·November 7, 2018
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 24, 2019
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·October 13, 2021
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·October 6, 2021
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 26, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 26, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·March 29, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class III
·Ongoing·Datascope Corp.·May 5, 2021