FDA Update: Agency Issues Letter on Getinge/Maquet/Datascope Cardiosave IABP Device Recalls
The U.S. Food and Drug Administration (FDA) issued a letter on Aug. 31 to update health care providers on the latest recalls and recommendations to users regarding Getinge/Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) devices.
“Since June 2023, Getinge/Maquet/Datascope initiated additional voluntary recalls related to the potential for device failure with Cardiosave Hybrid and Rescue IABP devices and provided mitigation strategies,” states the letter. “Six of these recalls the FDA classified as Class I.”
For more information and to view the full letter, access the FDA website.
Keywords: Aorta, Medical Device Recalls, ACC Advocacy
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