Facing Few Alternatives, FDA Has Provided Recommendations for Using Recalled Cardiosave Intra-Aorta Balloon Pumps

The FDA is warning that the devices can shut down unexpectedly, but issued recommendations for their continued use by medical providers

Two weeks after Getinge announced another recall for Cardiosave Hybrid and Rescue aorta balloon pumps, indicating that the critical heart devices may unexpectedly shut down, federal regulators have issued a series of recommendations for medical providers about how to continue using the devices safely, since there is a lack of viable alternatives.

The U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers on August 31, updating them on the latest Cardiosave balloon pump recall and listing recommendations about how the device should be used.

The FDA issued the letter as an update to an August 17 announcement of a class I recall for Cardiosave Intra-Aortic Balloon Pumps (IABP). However, persistent problems with the devices have led to more than half a dozen recall notices, with six of those classified as class I recalls by the agency, meaning the FDA believes problems with the devices can lead to severe injuries and death.

Few Alternatives to Recalled Cardiosave Intra-Aorta Balloon Pumps

In the letter, the FDA acknowledges there are few, if any, alternative treatments for patients who use IABPs, and a recall puts many patients at risk.

“While the FDA remains concerned about device shutdown and pump stop events, these devices may continue to be used to provide circulatory support when necessary,” the FDA letter states. “The FDA recognizes that alternative treatments are limited.”

The FDA said it is working with the manufacturer to evaluate the issues, but patients can continue to use the devices in the meantime. However, the agency is calling on healthcare providers to ensure they are aware of the latest recalls and recommendations for users, warning that the Cardiosave devices may unexpectedly shut down, which means therapy to the patient stops.

These shutdowns can occur due to:

• Electrical failures in the power management board or solenoid board.
• Failures in the printed circuit board and assembly in the charging path.
• The device is not being seated in the cart correctly, causing it to run on battery power and not charge the battery.
• The device being unable to refill the helium to continue therapy.
• Sensitive Gas Gain or Gas Loss alarms.
• Internal device temperature exceeds a threshold of 176°F.

Cardiosave IABP Recalls

The Cardiosave IABP devices have been plagued by more than half a dozen similar recalls linked to unexpected battery power loss since 2019. Before the most recent recall, another device removal was announced in in January due to balloon failures and tears.

The intra-aorta balloon pumps are used in healthcare facilities to temporarily help the heart pump properly for individuals with acute coronary syndrome, undergoing cardiac or non-cardiac surgery, or experiencing complications of heart failure.

The balloons are placed in the aorta and are meant to work together with an electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle. However, recalled pumps may fail, shutting down unexpectedly, which may result in unstable blood pressure, inadequate blood supply, or a vital organ injury.

The letter urges healthcare providers to:

• Be aware device failures continue to occur with the Cardiosave IABP devices.
• Consider having additional charged IABP devices available and ready in case of device failure.
• Review Urgent Medical Device Correction notices for information on issues related to the device failures.

The FDA also asks healthcare providers to return devices associated with adverse events, device malfunction, or device failure to the manufacturer for evaluation.

Customers with questions about the recalled Cardiosave devices should contact Getinge at 888-943-8872 and report any issues or adverse events with IABP devices to the FDA MedWatch Adverse Event Reporting program.