Getinge provides more information on FDA communication to health care providers
Following the release of the FDA communication to health care providers Getinge would like to provide the following information.On December 16, 2021, the American Food and Drug Administration (FDA) posted a Health Care Provider letter on the FDA Website regarding a Class 1 Recall for Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to reports of fluid leaks. Getinge performed a correction to these devices in May 2018. The current voluntary field correction is a further action to eliminate fluid ingress. Fluid entering the