In a flurry of Aug. 31 notices from the FDA, the number of Class I recalls plaguing Getinge’s Cardiosave intra-aortic balloon pumps this year has doubled.
The notices detailed four more recalls of the pumps that the agency has given its most serious rating, adding to the quartet of Class I tags that Getinge had already racked up since January.
All eight of this year’s recalls affect both Hybrid and Rescue models of the pumps, which are inserted into the descending aorta of patients experiencing cardiogenic shock. Once in place, the pump helps electromechanically inflate and deflate a connected intra-aortic balloon to help the left ventricle pump at a normal rhythm.
Nearly 9,200 of the recalled devices have been distributed around the world, with about half sold in the U.S. They were distributed over the course of about a decade, from March 2012 to May of this year.
Getinge began all four of the Cardiosave devices’ latest recalls at the end of July, and all concern malfunctions that could potentially lead to unexpected device shutdowns. If that happens and the pump suddenly stops working as needed, per the FDA, patients could experience unstable blood pressure, inadequate blood supply or vital organ injuries, among other serious injuries—or even death.
Each of the four issues has sparked complaints numbering in the hundreds, with each group of adverse event reports containing at least one report of a patient’s death.
In one case, the pumps have been found to overheat when their internal temperatures rise above 176 degrees Fahrenheit, triggering a “System Over Temperature” alarm and sending the affected pump into standby mode. That issue has been linked to 213 complaints since the start of 2021, including four injuries and one death.
The second recall notice covers instances in which the pump’s regular autofill process—in which the balloon catheter’s circuit is automatically filled with helium every two hours or any time there’s a change in atmospheric pressure—fails. Once again, this issue will trigger an alarm and send the device into standby. It’s been the subject of 298 complaints, including “up to three injuries,” per the FDA, and two deaths.
Another notice, meanwhile, describes how certain patient movements, the flow of blood into the device’s circuit or issues with the tubing or catheter may disrupt the regular flow of helium within the mechanism—causing the device to set off a “Gas Gain” or “Gas Loss” alarm and promptly shut down. That issue has sparked 198 complaints since 2021, including three injuries and two deaths.
Finally, the devices were also found to be at risk of unexpectedly shutting down due to a loss of power if their consoles aren’t correctly docked into the accompanying rolling cart, forcing them to run solely on easily-depleted battery power, rather than the cart’s AC power connection. The docking issue is linked to 533 complaints, including one patient death.
In an Aug. 31 letter sent to healthcare providers, the FDA provided information about the Cardiosave devices’ Class I recalls and said it is working with Getinge “to evaluate these issues.”
Still, the regulator said the devices’ benefits continue to outweigh any potential risks.
“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,” it wrote, adding, “The FDA recognizes that alternative treatments are limited.”
In the meantime, the agency urged healthcare providers to “strongly consider” keeping backup intra-aortic balloon pumps at the ready in case of sudden device failure and recommended that all staffers familiarize themselves with the various potential malfunctions.