The FDA is instructing healthcare facilities to avoid using two heart devices from Getinge amid concerns that the company has not adequately resolved issues that spurred a string of recalls over the last year.
Getinge has issued 12 recalls for its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump due to various quality and safety issues since 2023. The company has also initiated eight recalls for its Cardiohelp System and HLS sets since last year.
The FDA has received 33 reports of serious injury or death tied to the CardioHelp life support system and 15 reports linked to the balloon pump in the last 12 months. The agency noted it's difficult to establish a direct cause between an adverse event report and a specific device.
While Getinge took corrective steps after the recalls, the FDA said it is still receiving reports of issues with the devices.
In a May 8 letter to healthcare providers, the agency recommended organizations seek alternative devices when possible "based on concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices."
"We take this seriously and are in ongoing dialogue with the FDA to address the concerns in the best possible way," Elin Frostehav, president of acute care therapies at Getinge, told Becker's May 9.
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