UPDATE: Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps

Today, the U.S. Food and Drug Administration (FDA) is providing an update to our on our evaluation of device failure associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices. The FDA continues to receive reports about these devices shutting down while running on battery power, leading to pump stop and loss of hemodynamic support. Health care providers supporting cardiac patients with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps during transport should take the recommended steps outlined by the FDA to minimize the risk of patient harm.

Read the Letter to Health Care Providers

The FDA continues to work with the manufacturer to examine and address the root cause of these device failures and will keep the public informed if any significant new information or recommendations become available. Questions? If you have questions about this letter, contact the Division of Industry and Consumer Education.