FDA Update: Agency Recalls Select Cardiosave Hybrid and Rescue IABPs Due to Shutdown Risk From Coiled Cord Connection Failure
The U.S. Food and Drug Administration (FDA) announced that Datascope/Getinge is recalling Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) due to risk of a coiled cable connecting the display and base of the unit failing, causing an unexpected shutdown. This issue may occur in units distributed before July 24, 2017.
According to the agency, “an unexpected pump shutdown and any interruption to therapy that occurs can lead to hemodynamic instability, organ damage and/or death.” As a result, the FDA has labeled this a Class I recall, meaning use of these devices may cause serious injuries or death.
For more information and recommendations, access the FDA website.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support
Keywords: Medical Device Recalls, Hemodynamics, Heart-Assist Devices, United States Food and Drug Administration, ACC Advocacy
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