FDA Update: Agency Recalls Datascope/Getinge Cardiosave Hybrid and Rescue IABP

The U.S. Food and Drug Administration (FDA) announced a recall on Jan. 25 of the Datascope/Getinge Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue IABP due to risk that a burst, leaking or torn balloon can cause blood to enter the IABP during therapy, resulting in patient harm.

A compromised intra-aortic balloon causing "a blood back event" can lead to critical complications including unexpected pump shutdown, helium gas emboli (if therapy continues), patient blood loss, potential biohazard exposure to user and/or maintenance personnel, and potential cross-contaminated blood exposure to new patients.

As use of these devices may cause serious injuries or death, the FDA has classified this as a Class I recall. Access the Agency's website for more information and recommendations.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support

Keywords: ACC Advocacy, Helium, United States Food and Drug Administration, Hazardous Substances, Intra-Aortic Balloon Pumping, Heart-Assist Devices, Hemorrhage

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