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.Read More >>