Getinge’s intra-aortic balloon pumps seem to have lost their rhythm: Already this year, the devices have been the target of a handful of FDA Class I recalls in the U.S. and a CE mark suspension in Europe.
The most recent recall—in a familiar echo of the one before—was prompted by the discovery that some of the pumps could be at risk of shutting down without warning due to electrical issues. Getinge kicked off the recall in June, but it wasn’t until Thursday that the FDA issued a notice classifying the recall as Class I, the agency’s most serious rating.
According to the notice, electrical failures in the pumps’ power management or solenoid boards can lead to unexpected shutdowns of the entire mechanism. Because the pumps are used to mechanically inflate and deflate intra-aortic balloons, guiding the heart to beat at a normal rhythm, if the device suddenly stops working, it could destabilize a patient’s blood pressure, injure a vital organ, lead to inadequate blood supply or even result in death.
Separately, the FDA handed down another Class I rating to a second issue with the pumps outlined in the same June recall notice. In that case, due to a flaw in the device’s design, the pumps’ charging bay slots may lose their ability to charge their own batteries.
If that happens and the pumps are also disconnected from AC power, the pump may fully lose power, causing yet another interruption in the heart-pumping therapy. Before they completely lose power, however, the pumps may emit a low battery alarm to warn users, according to the FDA.
Both of the recalls cover Cardiosave Hybrid and Cardiosave Rescue models of the intra-aortic balloon pumps that were distributed over the span of more than a decade, between March 2012 and mid-May of this year. That comprises nearly 9,200 of the devices that were sold around the world during that period, about half of which were distributed in the U.S.
To date, according to the FDA’s notice, Getinge has received 26 complaints related to the shutdown issue, with no reports of patient injuries or death.
In a letter sent to healthcare providers using the affected Cardiosave pumps, per the FDA, Getinge recommended that they keep an alternative pump on hand so that they’re able to continue a patient’s therapy in case a shutdown occurs. If another intra-aortic balloon pump isn’t available to provide counterpulsation therapy, they should find another device that can offer the needed hemodynamic support—a technology class that includes ventricular assist devices, extracorporeal membrane oxygenation machines and more.
To mitigate the battery issues, meanwhile, clinicians shouldn’t remove a device’s battery if it’s connected to AC power to charge and is at least 80% full; according to Getinge, the batteries should remain in their charging bays until they’ve been fully charged.
The latest recalls come not long after the Cardiosave pumps’ last Class I tag. That rebuke arrived in the spring and covered 8,900 Hybrid and Rescue models that were once again found to be at risk of unexpected shutdowns—this time, caused by a loss of communication between the printed circuit board assemblies of the pumps’ executive processors and video generators.
As of the agency’s early April notice, that recall had sparked 42 complaints but no reports of injury or death.
More troublesome, however, was yet another recall of the pumps that earned a Class I rating at the start of this year. In that case, Getinge found that tears or other damage to the balloons could cause blood to flow into the pump’s mechanism, potentially causing the device to shut down and, in some cases, send helium out from the balloon into the bloodstream, creating emboli that could block blood flow throughout the body.
The recall was linked to 134 complaints between October 2018 and November 2022. Five of those complaints detailed adverse patient events, including four serious injuries and one death.
Not long after that recall began, German notified body TÜV SÜD temporarily revoked the pumps’ CE mark, preventing them from being sold in Europe for three months. In its late March announcement, Getinge said it would use the time to rectify certain issues in its “risk management, post-market surveillance and vigilance” and in how it had responded to the devices’ previous safety issues.