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FDA Advises Healthcare Facilities to Transition Away from Getinge’s Heart Devices Due to Safety Concerns

The U.S. Food and Drug Administration (FDA) has issued a recommendation urging healthcare facilities to discontinue the use of Getinge’s heart devices, including the Cardiohelp system and HLS Sets, as well as the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. This advisory comes in response to ongoing safety and quality concerns despite multiple…

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