15 results
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9ms
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Sources: EU EUDAMED, US FDA
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 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 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 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 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 Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 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, 0998-UC-0800-55. 2. Cardiosave Rescue. Model Number: 0998-00-0800-83.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·October 27, 2021
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015