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Datascope Corp. FDA Recalls
60 recalls on file across devices, 25 of them Class I and 60 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Battery Charging Station; Model: 0998-00-0802;Class IIIFeb 6, 2026The Battery Charging Station is an optional dual-bay charge |
| CS300 IABP. Software Version CS300 IABP C.01.Class IIJan 23, 2026The firm has identified that the battery runtime and cycle s |
| CS100 IABP. Software Version CS100 IABP Q.01.Class IIJan 23, 2026The firm has identified that the battery runtime and cycle s |
| Cardiosave Hybrid. Intra-Aortic Balloon Pump system.Class IINov 4, 2025The IFU addendum revises the Preventative Maintenance schedu |
| Cardiosave Rescue. Intra-Aortic Balloon Pump system.Class IINov 4, 2025The IFU addendum revises the Preventative Maintenance schedu |
| Cardiosave HybridClass IIIOct 23, 2025The IFU addendum updates the Vibration and Shock Table to re |
| Cardiosave RescueClass IIIOct 23, 2025The IFU addendum updates the Vibration and Shock Table to re |
| MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01Class IISep 17, 2024There is discrepant labeling on the inner and outer packagin |
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic baClass IAug 8, 2024Firm has developed a software correction (Revision D.01) for |
| CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic baClass IAug 8, 2024Firm has developed a software correction (Revision D.00) out |
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic baClass IAug 8, 2024Firm has developed a software correction (Revision D.00) out |
| CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic baClass IAug 8, 2024Firm has developed a software correction (Revision D.01) for |
| Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85Class IJul 31, 2023Users were reporting that the device was not charging as exp |
| Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099Class IJul 31, 2023Users were reporting instances of "Gas Loss in IAB Circuit" |
| Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85Class IJul 31, 2023Users were reporting instances of "Gas Loss in IAB Circuit" |
| Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85Class IIJul 31, 2023Users were experiencing a failure in the IAB Fiber Optic Sen |
| Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85Class IJul 31, 2023Users were identifying autofill failure conditions on the de |
| Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099Class IJul 31, 2023Users were reporting that the device was not charging as exp |
| Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099Class IJul 31, 2023Users reported "System Over Temperature" alarms associated w |
| Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099Class IIJul 31, 2023Users were experiencing a failure in the IAB Fiber Optic Sen |
| Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099Class IJul 31, 2023Users were identifying autofill failure conditions on the de |
| Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 099Class IJul 31, 2023Users reported "System Over Temperature" alarms associated w |
| LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Class IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Class IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Class IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Class IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in tClass IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorClass IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in thClass IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Class IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in theClass IIJun 23, 2023During IAB catheter insertion, the introducer dilator may fr |
| Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85Class IJun 5, 2023IABP may lose the ability to charge batteries in one or both |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0Class IJun 5, 2023An unexpected shutdown of the IABP may occur due to failures |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0Class IJun 5, 2023IABP may lose the ability to charge batteries in one or both |
| Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85Class IJun 5, 2023An unexpected shutdown of the IABP may occur due to failures |
| Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XXClass IIIMay 4, 2023The digital IFUs provided with the Cardiosave IABP during th |
| MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32Class IIApr 4, 2023The power cord supplied (Type J plug end) for the Cardiosa |
| Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140Class IIFeb 28, 2023There is an issue related to the Safety Disk not meeting a p |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099Class IIFeb 28, 2023There is an issue related to the Safety Disk not meeting a p |
| Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178Class IIFeb 28, 2023There is an issue related to the Safety Disk not meeting a p |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-0Class IIFeb 28, 2023There is an issue related to the Safety Disk not meeting a p |
| Cardiosave Rescue. Model Number: 0998-00-0800-83.Class IIFeb 7, 2023Firm has received reports of damaged, worn, or torn O-rings |
| Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model NumbeClass IFeb 7, 2023An unexpected shutdown of the IABP may occur due to a failur |
| Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85Class IFeb 7, 2023An unexpected shutdown of the IABP may occur due to loss of |
| Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0Class IIFeb 7, 2023Firm has received reports of damaged, worn, or torn O-rings |
| Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85Class IIFeb 7, 2023There have been reported failures of the high pressure heliu |
| Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model NumbeClass IFeb 7, 2023An unexpected shutdown of the IABP may occur due to a failur |
| Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 099Class IFeb 7, 2023An unexpected shutdown of the IABP may occur due to loss of |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099Class IIFeb 7, 2023There have been reported failures of the high pressure heliu |
| Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 099Class IDec 19, 2022The Cardiosave IABP may shut down unexpectedly due to blood |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099Class IDec 19, 2022The Cardiosave IABP may shut down unexpectedly due to blood |
| Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-08Class INov 15, 2021Firm is initiating a correction due to the possibility of fl |
| Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-08Class INov 15, 2021Firm is initiating a correction due to the possibility of fl |
| Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IAClass ISep 21, 2021A Cardiosave Lithium-Ion Battery Pack used during protocol t |
| Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85Class IISep 8, 2021The Cardiosave IABP may unexpectedly shut down when the devi |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-0Class IISep 8, 2021The Helium Indicator on the Cardiosave display may over repr |
| Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-0Class IISep 8, 2021The Cardiosave IABP may unexpectedly shut down when the devi |
| Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85Class IISep 8, 2021The Helium Indicator on the Cardiosave display may over repr |
| Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary supportClass IIIMar 22, 2021There are cybersecurity vulnerabilities in a widely used low |
| Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary supportClass IIIMar 22, 2021There are cybersecurity vulnerabilities in a widely used low |