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Datascope Corp.

FDA Regulatory Profile

Summary

Total Recalls
66 (31 Class I)
510(k) Clearances
136
Inspections
8
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-1487-2026Class IICS300 IABP. Software Version CS300 IABP C.01.January 23, 2026
Z-1486-2026Class IICS100 IABP. Software Version CS100 IABP Q.01.January 23, 2026
Z-0917-2026Class IICardiosave Rescue. Intra-Aortic Balloon Pump system.November 4, 2025
Z-0916-2026Class IICardiosave Hybrid. Intra-Aortic Balloon Pump system.November 4, 2025
Z-0931-2026Class IIICardiosave HybridOctober 23, 2025
Z-0932-2026Class IIICardiosave RescueOctober 23, 2025
Z-0311-2025Class IIMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01September 17, 2024
Z-3137-2024Class ICARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and defAugust 8, 2024
Z-3136-2024Class ICARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and defAugust 8, 2024
Z-3134-2024Class ICARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and defAugust 8, 2024
Z-3135-2024Class ICARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and defAugust 8, 2024
Z-2486-2023Class IICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, July 31, 2023
Z-2435-2023Class ICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, July 31, 2023
Z-2436-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, July 31, 2023
Z-2438-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, July 31, 2023
Z-2431-2023Class ICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, July 31, 2023
Z-2487-2023Class IICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, July 31, 2023
Z-2432-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, July 31, 2023
Z-2437-2023Class ICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, July 31, 2023
Z-2434-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, July 31, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDecember 26, 2019
K181122CARDIOSAVE Intra-Aortic Balloon PumpMay 31, 2018
K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpOctober 12, 2017
K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and StorJanuary 31, 2017
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpJuly 2, 2015
K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDecember 12, 2013
K071805NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XXSeptember 25, 2007
K062569SAFEGUARD 24 CM PRESSURE ASSISTED DRESSINGFebruary 14, 2007
K062098SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXXFebruary 5, 2007
K063525DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PJanuary 5, 2007
K062754GAS MODULE SE, MODEL 0998-00-0481-02November 2, 2006
K051897TRIO MONITORAugust 12, 2005
K042016DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETERSeptember 23, 2004
K041907TRIO MONITORJuly 23, 2004
K041281DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIESJune 7, 2004
K032338TRIO MONITOR MODEL 0998-00-0600February 11, 2004
K031760VIEWPOINT TELEMETRY SYSTEMOctober 10, 2003
K031849SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXXSeptember 9, 2003
K031636CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XXAugust 11, 2003
K031569DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XXJune 10, 2003