Datascope/Maquet/Getinge has recalled the Cardiosave Hybrid Intra-Aortic Balloon Pump and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board.
The Cardiosave Hybrid and the Cardiosave Rescue are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counterpulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle.
Cardiosave Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.
Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury, and death. The FDA has identified this as a Class I recall, the most serious type of recall.
Datascope/Maquet/Getinge reported 26 complaints. There have been no reports of injuries or death. The recall affects 4,586 devices that were distributed from March 6, 2012, to May 19, 2023.
On June 5, Datascope/Maquet/Getinge sent all affected customers an Important Medical Device Advisory. The letter requested customers to ensure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their Datascope/Maquet/Getinge representative or call Datascope/Maquet/Getinge technical support at 1-888-943-8872.
