Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

Yet another recall—the second in the space of a week—has been announced by the Food and Drug Administration for the Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). And yet again, the agency is categorizing the recall as Class I, its most serious type.

This time around, Datascope/Maquet/Getinge recalled the devices “because they may shutdown unexpectedly due to failures in the printed circuit board assembly (PCBA) in the charging path. If this occurs, the device may lose the ability to charge batteries in one or both battery bays/slots due to electrical surge damage in the Power Management Board Charging Path Circuit,” according to the FDA.

“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 says.

The recall applies to 4,586 IABPs distributed between March 6, 2012, and May 19, 2023.

To date, the manufacturer has received 252 complaints about the problem, but there have been no reported injuries or deaths. They initiated both this recall and the one before on June 5; the FDA alert on August 10 also pertained to the Cardiosave Hybrid and Rescue unexpectedly shutting down, but due to electrical failures in the power management board or solenoid board (power source path).

This is now the fifth 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 PCBA 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 other problems with the Cardiosave devices. The IABPs were recalled due to fluid leaks in December 2021 and because of battery problems in October 2021. 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).