Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) are once again being recalled, this time because of potential electrical failures that could result in patient injuries or death, according to an announcement today from the US Food and Drug Administration.

The FDA has designated this a Class I recall, the most serious type. To date, the manufacturer has received 26 complaints about this problem with the IABPs, but there have been no reported injuries or deaths.

Datascope/Maquet/Getinge began recalling 4,586 IABPs in June 2023 because the devices may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path). The pumps are used in cardiac and noncardiac surgeries to provide temporary support to the left ventricle through counter pulsation.

“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,” the FDA announcement notes.

This is the fourth recall of the Cardiosave Hybrid and Rescue IABPs this year.

In March, 4,500 units were recalled because of a communication loss between the executive processed printed circuit board assembly and video generator. The week before that, the IABPs were recalled due to the possibility that a coiled cable connecting the display and base may fail, leading to an unexpected shutdown and inability to restart. In January, the devices were recalled because of potential damage to the balloon catheter that might permit blood to flow into the pump. These were all Class I recalls.

There have been a host of problems with the Cardiosave devices, with at least eight recalls since 2017. In December 2021, the IABPs were recalled due to fluid leaks and in October 2021 because of battery problems. Before those, there were recalls related to potential electrical test failure (June 2017), failure of the device valve (August 2017), fluid ingress (September 2017 and June 2018), possible failure at high altitudes (November 2018), and potential battery failure (July 2019).