Amid CE mark suspension, Getinge cardiac balloon pumps hit with 2nd Class I recall this year

Just a week after Getinge temporarily lost CE mark clearance in Europe for its Cardiosave intra-aortic balloon pumps, the FDA has handed down a Class I recall rating to the devices—the second such label this year.

The Cardiosave pumps help mechanically inflate and deflate an intra-aortic balloon to help keep blood pumping normally throughout the body. Intra-aortic balloons and their pumps are used in hospital settings, often as part of treatments for acute coronary syndrome, complications associated with heart failure and recovery from heart surgery.

The recall affects just over 8,900 of the Hybrid and Rescue models of the balloon pumps, more than half of which were distributed in the U.S. The affected devices date back more than a decade: According to the FDA’s recall notice, they include those distributed between March 2012 and January of this year, when Getinge began the recall.

The recall comes after Getinge and its Datascope subsidiary discovered that the affected devices may shut down unexpectedly during use, without issuing any alarms or warnings. The shutdowns are caused by a loss of communication between the printed circuit board assemblies (PCBAs) of the Cardiosave devices’ executive processors and video generators.

According to the recall notice, once that disconnect occurs and a device shuts down, it won’t work again until one or both of the PCBAs is replaced. In the meantime, a shutdown could interrupt a patient’s blood flow and lead to organ damage or even death.

As of the FDA’s notice this week, Getinge has so far passed on to the agency 42 complaints about unexpected shutdowns caused by PCBA communication failures—though none of the complaints contain reports of injuries or death.

The issue has been attributed to faulty software design, and Getinge has already developed a correction to fix the flaw, which will be rolled out to customers once it’s available. Until then, the devices can still be used, but Getinge has asked healthcare providers to ensure all clinicians who come into contact with the devices are aware of the risk of shutdowns and have another balloon pump at the ready in case the issue crops up during use.

Though Cardiosave balloon pumps that have already been distributed can still be used in spite of the recall, Getinge won’t be selling any new pumps in Europe for the next few months. Last week, the Swedish devicemaker announced that a Germany-based notified body had moved to suspend the CE mark for the pumps, effective immediately.

Getinge now has three months to fix several issues identified in the suspension, which was “based on concerns related to risk management, post-market surveillance and vigilance, as well as information pertaining to timeliness of field safety corrective actions,” according to the company.

Both the suspension and the latest recall come not long after the Cardiosave devices were hit with yet another Class I recall from the FDA. That one, which earned the high-risk label in January after the recall began in December, came after the Hybrid and Rescue models were found to be at risk of shutting down if the attached balloon tears or bursts and allows blood to leak into the pump.