FDA – Class I recall of Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs)

Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board or Solenoid Board (Power Source Path).

Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death.

Datascope/Maquet/Getinge reported 26 complaints. There have been no reports of injuries, or death.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and the Cardiosave Rescue IABP are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. 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. They are used in health care facilities.

Recalled Product:
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)

Product Models:
Cardiosave Hybrid
Cardiosave Rescue

Distribution Dates: March 6, 2012 to May 19, 2023
Devices Distributed in the U.S.: 4586
Date Initiated by Firm: June 5, 2023