Following 12 company recalls and nearly 3,000 reported issues related to its cardiovascular life support systems since January 2023, Getinge has now drawn more scrutiny from the FDA — as the agency urges providers to stop using the devices altogether.
The company’s Maquet and Cardiosave lines of intra-aortic balloon pumps and catheters — as well as its Cardiohelp hardware used during cardiopulmonary bypass surgery — have seen issues ranging from unexpected shutdowns and backup power concerns, to leaks of helium that could cause an embolism within the patient.
“The FDA recommends that health care facilities transition away from use of these devices and seek alternatives, if possible,” the agency said in a letter to healthcare providers this week. “These recommendations are based on our continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.”
The FDA added that it has continued to receive device reports even after Getinge took corrective actions — including a campaign to educate providers on the devices’ proper operation, as well as a list of new actions they can take when employing the balloon pumps.
“We take this seriously and are in ongoing dialogue with the FDA to address the concerns in the best possible way,” Elin Frostehav, Getinge's president of acute care therapies, said in a statement to Fierce Medtech.
The Cardiosave system is threaded into the aortic artery, where it repeatedly inflates and deflates a balloon catheter in sync with the patient’s heartbeat, to interrupt blood flow and ease cardiac function.
Cardiohelp, meanwhile, oxygenates blood during bypass procedures. It features a hand crank to power the system and keep the blood flowing during an emergency, but a Class I recall late last year highlighted issues that could stop the crank from being properly turned.
The FDA said it is aware that alternative treatment options for both systems are limited, but still urged hospitals to plan to invest in different capital equipment.
“The FDA continues to work with the Getinge to understand factors contributing to the device failures, as well as possible mitigation strategies,” the agency added. “The FDA is working with other manufacturers to assess their interest and ability to manufacture and distribute alternative devices in the U.S.”
The systems have also been taken off the market in the European Union, most recently after Cardiosave’s CE Mark was temporarily suspended for six months beginning in early March. The Munich, Germany-based EU notified body Tüv Süd said that Getinge’s Datascope subsidiary had only “partially fulfilled” previously set device compliance conditions, after a CE Mark was suspended last year for three months.
Specifically, Tüv Süd asked Getinge to speed up its efforts to improve and correct its hardware, but the Swedish company has said that component and supply chain shortages have forced it to fall behind on its timeline.