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BioWorld - Friday, December 12, 2025
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Home » Abiomed, Datascope facing new round of recalls for cardiovascular devices
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Abiomed, Datascope facing new round of recalls for cardiovascular devices

Aug. 21, 2023
The markets for ventricular assist devices (VADs) and intraortic balloon pumps (IABPs) are hardly littered with competition, but the few companies that work in these two device categories have faced seemingly routine recalls over the past couple of years. The U.S. FDA recently reported yet another round of class I recalls for a single model in both Abiomed Inc.’s Impella line of VADs and Datascope Corp.’s Cardiosave line of IABPs, but the agency’s apparent unwillingness to force either manufacturer to withdraw any of these recalled products seems to suggest that product shortages would quickly follow any such move on the FDA’s part.
BioWorld MedTech Regulatory Cardiovascular U.S. FDA

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