The FDA issued a notice determining a recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind.
This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in December 2021.
Getinge’s Datascope subsidiary initiated their latest recall of an estimated 2,300 devices on Jan. 9, 2023. They distributed affected devices between March 6, 2012 and July 20, 2017, according to an FDA notice.
To date, Getinge received 44 complaints related to the latest issue with no reported injury or death.
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