Datascope Corp.
Mahwah, NJ
This page shows every FDA and USDA recall linked to Datascope Corp.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
67
Total Recalls
2003
First Recall
2026
Most Recent
CS300 IABP. Software Version CS300 IABP C.01.
Mar 3, 2026
· Device
Open, Classified
CS100 IABP. Software Version CS100 IABP Q.01.
Mar 3, 2026
· Device
Open, Classified
Cardiosave Rescue
Dec 16, 2025
· Device
Open, Classified
Cardiosave Hybrid
Dec 16, 2025
· Device
Open, Classified
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Dec 11, 2025
· Device
Open, Classified
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Dec 11, 2025
· Device
Open, Classified
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra...
Sep 20, 2024
· Device
Open, Classified
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra...
Sep 20, 2024
· Device
Open, Classified
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra...
Sep 20, 2024
· Device
Open, Classified
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra...
Sep 20, 2024
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-08...
Aug 31, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-08...
Aug 31, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-08...
Aug 30, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers
0998-00-0800-31
0998-00-0800-32
0998-00-080...
Jul 20, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers
0998-00-0800-75
0998-00-0800-83
0998-00-080...
Jul 20, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers
0998-00-0800-31
0998-00-0800-32
0998-00-080...
Jul 19, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers
0998-00-0800-75
0998-00-0800-83
0998-00-080...
Jul 19, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Jun 14, 2023
· Device
Open, Classified
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Apr 26, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-...
Mar 22, 2023
· Device
Open, Classified
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Mar 22, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-08...
Mar 22, 2023
· Device
Open, Classified
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Mar 22, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, M...
Mar 9, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, M...
Mar 9, 2023
· Device
Open, Classified
Cardiosave Hybrid
Model Nos. 0998-00-0800-31
0998-00-0800-32
0998-00-0800-33
0998-00-0800-34
0998-00-0800-35...
Mar 9, 2023
· Device
Open, Classified
Cardiosave Rescue
Model Nos.
0998-00-0800-75
0998-00-0800-83
0998-00-0800-85
Mar 9, 2023
· Device
Open, Classified
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Mar 6, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-08...
Mar 6, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33,...
Mar 6, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-0...
Mar 6, 2023
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-08...
Jan 19, 2023
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-08...
Jan 19, 2023
· Device
Open, Classified
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,...
Dec 30, 2021
· Device
Open, Classified
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83,...
Dec 30, 2021
· Device
Open, Classified
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloo...
Oct 20, 2021
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-...
Oct 7, 2021
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-...
Oct 7, 2021
· Device
Open, Classified
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-...
Sep 8, 2021
· Device
Open, Classified
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-...
Sep 8, 2021
· Device
Open, Classified
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides tempora...
Apr 28, 2021
· Device
Open, Classified
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides tempora...
Apr 28, 2021
· Device
Open, Classified
Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon
P...
Oct 3, 2019
· Device
Terminated