Brand

Datascope Corp. Recalls

45 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Datascope Corp..

45Total Recalls
26Critical
1.9MUnits Affected
Feb 6, 2026Most Recent
All Recalls

Every Datascope Corp. Recall

Sorted by most recent. Click any recall for full details.

45 recalls
RecallFDA
Datascope Corp.
Battery Charging Station; Model: 0998-00-0802;
Medical Devices·28 affected·Feb 6, 2026
High RiskFDA
Datascope Corp.
CS300 IABP. Software Version CS300 IABP C.01.
Medical Devices·10,897 affected·Jan 23, 2026
High RiskFDA
Datascope Corp.
CS100 IABP. Software Version CS100 IABP Q.01.
Medical Devices·10,897 affected·Jan 23, 2026
High RiskFDA
Datascope Corp.
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Medical Devices·47 affected·Nov 4, 2025
High RiskFDA
Datascope Corp.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Medical Devices·11,470 affected·Nov 4, 2025
RecallFDA
Datascope Corp.
Cardiosave Rescue
Medical Devices·47 affected·Oct 23, 2025
RecallFDA
Datascope Corp.
Cardiosave Hybrid
Medical Devices·11,470 affected·Oct 23, 2025
High RiskFDA
Datascope Corp.
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Medical Devices·160 affected·Sep 17, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
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, 099...
Medical Devices·9,175 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
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, 099...
Medical Devices·9,175 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
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, 099...
Medical Devices·11,574 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·9,175 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·9,175 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descri...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product D...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Descrip...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Produc...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descripti...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
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 0...
Medical Devices·9,174 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Medical Devices·9,174 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
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 0...
Medical Devices·9,174 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Medical Devices·9,174 affected·Jun 5, 2023
RecallFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Medical Devices·4 affected·May 4, 2023
High RiskFDA
Datascope Corp.
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Medical Devices·54 affected·Apr 4, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 099...
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Medical Devices·8,909 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0...
Medical Devices·11,792 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Medical Devices·47 affected·Feb 7, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 099...
Medical Devices·4,793 affected·Feb 7, 2023
CriticalFDA
Datascope Corp.
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, 099...
Medical Devices·11,906 affected·Dec 19, 2022
CriticalFDA
Datascope Corp.
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-08...
Medical Devices·44 affected·Nov 15, 2021
CriticalFDA
Datascope Corp.
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the belo...
Medical Devices·131 affected·Sep 21, 2021
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-0...
Medical Devices·3,969 affected·Sep 8, 2021
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-0...
Medical Devices·5,054 affected·Sep 8, 2021
RecallFDA
Datascope Corp.
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left vent...
Medical Devices·10,087 affected·Mar 22, 2021
High RiskFDA
Datascope Corp.
Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number ...
Medical Devices·7 affected·Oct 3, 2019
CriticalFDA
Datascope Corp.
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Medical Devices·6,197 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019