March 20, 2023

FDA: Class I recall of certain Datascope/Getinge IABPs

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on March 17 identified the recall by Datascope/Getinge of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious.

The recall was initiated because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown.

From June 2019 to August 2022, Datascope/Getinge has reported 44 complaints of damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths.

The issue may occur in units distributed before July 24, 2017, and/or coiled cord part number 0012-00-1801. The company has developed a hardware correction to address this issue, and a service representative will contact customers to schedule installation when the correction kit is available.


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