FDA Update: Agency Announces Recall of Datascope/Maquet/Getinge Cardiosave Hybrid and Rescue IABPs

The U.S. Food and Drug Administration (FDA) announced on Aug. 17 that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Ballon Pumps (IABPs) due to failures in the printed circuit board assembly in the charging path, which may affect the device’s ability to charge the batteries and lead to unexpected shutdowns.

According to the agency, “using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death.”

For more information and recommendations, access the FDA website.

Keywords: Aorta, Blood Pressure, Vital Signs, United States Food and Drug Administration, ACC Advocacy

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