September 25, 2018

FDA: Getinge recalls Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on September 30 posted an announcement by Getinge that it is voluntarily initiating a worldwide recall involving a field correction of some 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp.

The recall is because of the potential for interruption and/or inability to start therapy to the patient when using certain intra-aortic balloons before or during use with the Cardiosave IABP at altitudes above 3,200 feet. This could lead to patient hemodynamic instability.

Maquet/Getinge is developing a software correction to address the altitude issue. Installation of the updated software is anticipated to begin February 2019.

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