FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps

Editor's Note

The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers.

Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five of the reports describe three patient deaths, though the deaths cannot definitively be attributed to the device shut down, the FDA says. Other reports describe serious patient injury, such as sudden drop in blood pressure or need for resuscitation.

At least six reports said there was no alarm warning before the IABP shut down. In addition, there are reports of battery issues that could lead to patient harm, including the device not charging the battery, the battery charge indicator not working properly, and the battery depleting sooner than expected.

The root cause or incidence rate of the IABPs shutting down while on batteries is not known. The FDA will keep the public informed if significant new information becomes available.