Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

(UPDATED) The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been placed under recall by the manufacturer (Getinge/Datascope/Maquet) following reports of fluid leaks, the US Food and Drug Administration announced last Thursday. The agency deemed the action a Class I recall, the most serious type.

The recall was initiated on October 27, 2021, following reports of fluid leaks, which “may cause unexpected pump shutdown or the inability to initiate therapy,” according to the FDA announcement. One death and 71 complaints have been linked to the problem.

In an Urgent Medical Device Correction Letter sent on November 15, 2021, Getinge/Datascope/Maquet advised users of the IABPs to following the instructions for use and to never place fluids on top of the units. “In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists,” the company said. And when the Cardiosave Rescue is deployed outside, use the plastic weather display and rescue cover.

The affected IABPs do not need to be returned to the company, which said it plans to upgrade the devices in the field to address the problem.

The recall covers 4,338 devices distributed in the US between March 6, 2012, and October 21, 2021.

IABPs from Getinge/Datascope/Maquet have been subject to numerous recalls over the years, including—most recently—one at the end of October 2021 related to battery problems. Prior recalls were tied 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).

This week, the FDA provided an update on its evaluation of the potential for device failure with the company’s IABPs, including the Cardiosave Hybrid and Rescue, CS300, and CS100/100i, saying it “recently became aware that . . . Cardiosave Hybrid and Rescue IABP devices may not recognize AC/wall power when devices are plugged in, which may lead to devices unexpectedly shutting down.”

The agency said it wants to make sure healthcare professionals and users of the devices are aware of the potential shutdown issue and the recent recalls. “While the FDA remains concerned about device shutdown events associated with Maquet/Datascope IABP devices, the FDA recognizes that these systems may be the best option for circulatory support for some patients.”