Recalls For Datascope And Abiomed Designated Class I

The US FDA has updated a recall of Datascope Cardiosave IABPs to reflect its class I high-risk status and announced a recall of the labeling for Abiomed’s Impella RP Flex.

FDA recall text on white notepad paper on blue background. — • Source: Shutterstock

The US Food and Drug Administration released information about two cardiac device recalls on 17 August, including the classification of an ongoing recall of Datascope Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as well as a new recall of the labeling for Abiomed’s Impella RP Flex with SmartAssist.

Both recalls have been designated as class I, the FDA’s highest-risk level.