4 further Class I recalls and 6 reported patient fatalities further deflate Getinge heart balloon pumps

The FDA recently issued a series of notices announcing that the number of Class I recalls associated with Getinge’s Cardiosave intra-aortic balloon pumps has doubled this year. These notices provided detailed information on four additional recalls of the pumps, all of which have received the agency’s most severe rating. This adds to the previous four Class I recalls that Getinge had already experienced since January. 

It is worth noting that all eight recalls in 2023 pertain to both the Hybrid and Rescue models of the pumps, which are designed for insertion into the descending aorta of patients suffering from cardiogenic shock. Once in position, these pumps play a critical role in electromechanically inflating and deflating an intra-aortic balloon, assisting the left ventricle in maintaining a normal rhythm.

The impact of these recalls has been widespread, with approximately 9,200 of these devices distributed worldwide, with about half of them sold in the United States. These distributions spanned a period of roughly a decade, from March 2012 to May of the current year. Getinge initiated all four of the latest Cardiosave device recalls in late July. These recalls primarily revolve around malfunctions that could potentially result in unexpected shutdowns of the devices. According to the FDA, if these pumps suddenly cease to function as required, patients could face severe consequences such as unstable blood pressure, insufficient blood supply, injuries to vital organs, or even fatal outcomes. Each of the four issues prompting these recalls has generated hundreds of complaints, with each group of adverse event reports including at least one report of a patient’s death.

In one instance, the pumps exhibited overheating when their internal temperatures surpassed 176 degrees Fahrenheit. This triggers a “System Over Temperature” alarm, causing the affected pump to enter standby mode. This issue has been associated with 213 complaints since the beginning of 2021, resulting in four injuries and one fatality. Another recall notice addresses situations where the pump’s regular autofill process, which involves automatically filling the balloon catheter’s circuit with helium every two hours or in response to changes in atmospheric pressure, fails. Once again, this issue triggers an alarm, placing the device in standby mode. This particular problem has been the subject of 298 complaints, including “up to three injuries,” as per the FDA, and two deaths.

Furthermore, another notice describes how certain patient movements, blood flow fluctuations into the device’s circuit, or issues with the tubing or catheter can disrupt the regular flow of helium within the mechanism. This, in turn, causes the device to trigger a “Gas Gain” or “Gas Loss” alarm and promptly shut down. Since 2021, this issue has sparked 198 complaints, resulting in three injuries and two deaths. Finally, the devices have also been found to be at risk of unexpected shutdowns due to a power loss if their consoles are not correctly docked into the accompanying rolling cart, causing them to rely solely on easily drained battery power rather than the cart’s AC power connection. The docking issue has resulted in 533 complaints, including one patient death.