Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps Recall: Patient Injury Risk

More than 5,000 intra-aortic balloon pumps are being recalled due to a software problem that could cause the device to fail to initiate therapy sessions or unexpectedly stop during use, posing an increased risk of cardiovascular failure and shock. 

The Maquet/Getinge Cardiovascular Intra-Aortic Balloon Pump (IABP) recall was announced by the FDA on September 20, after the manufacturer recognized the potential for the devices to fail to start when used at certain altitudes, increasing the risk of injury or death to patients.

The recalled IABP’s help the patient’s heart pump more blood throughout the body. The devices consist of a catheter which has a long balloon attached to one end, and a computer console at the other end. The console is programmed to inflate and deflate the balloon at the proper rate when the heart beats to help circulate blood flow.

The recall came after officials discovered patients using the IABP devices at altitudes above 3,200 feet could be at risk of the machine failing to start therapy sessions or turning off unexpectedly during treatment. This could leave patients at an increased of hemodynamic instability, which could result in circulatory collapse, shock, decompression shock, hypoperfusion, and cardiovascular failure.

Marquet/Getinge announced they will be developing a software fix for the issue by February 2019. For those receiving IABP treatments, healthcare providers are being asked to use the CS100 and CS300 IABP models as an alternative until the software on the recalled models is upgraded.

For a full list of the recalled devices including brand name, size and operating altitudes please visit the official IABP recall notice.

Customers are being encouraged to contact the company at 1-973-709-7967 or email them at Helena.swam@gentinge.com for any questions or concerns regarding the recall. Medical facilities will be receiving notice to stop using the recalled devices and to speak with their patients about the need to use an alternative device until the software on the recalled models are updated.