Getinge/Datascope/Maquet is recalling Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to complaints of fluid leaks.
The CardioSave Hybrid/Rescue IABPs are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.
There has been 1 death and 71 complaints reported about this device issue. Getinge/Datascope/Maquet plans to correct all IABP devices in the field to include various internal and external component upgrades that will be made available in an Ingress Prevention Upgrade Kit and will be installed by a Getinge/Datascope service representative.
Food and Drug Administration (FDA). Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks. December 16, 2021. Available at: click here. Accessed December 16, 2021.