FDA recalls 2K Datascope heart balloon pumps

More than 2,000 heart balloon pumps are part of a Class I recall issued by the FDA.

The two models being recalled — Cardiosave Hybrid and Rescue pumps made by Datascope, a subsidiary of Getinge — have been reported to unexpectedly shut down due to a malfunction of a coiled cable that connects the display to the device's base. 

A Class I recall is the most severe issuance from the FDA; it means a device could "cause serious injuries or death." 

"From June 2019 to August 2022, Datascope/Getinge has reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns," the agency said. "There have been no reports of injuries or deaths related to this issue."

This is the second time in just over a year that the FDA has issued a recall of these specific balloon pump models. In January 2022, the FDA cited fluid leaks from the pumps as the issue prompting a recall. At that time, the issues resulted in one death and 71 complaints, according to the agency.

 "All affected customers have been informed about the potential issue, which is limited to units distributed prior to July 24, 2017," a spokesperson for Getinge told Becker's. "Our service representatives will contact the customers to schedule an installation to correct the issue."

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars