Several years into the process of rectifying potential breaches in the sterile packaging of its life support systems—a process that has been littered with field correction notices and FDA-rated ...

Getinge said Tuesday it has paused promotional activities of certain balloon pumps and cardiopulmonary bypass devices in the U.S. The company, which is limiting sales to customers that lack ...

Certain cardiovascular devices made by Getinge/Maquet remain problematic and should be avoided if possible, the US Food and Drug Administration said Wednesday in a letter to healthcare providers. The ...

The warning covers Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets Physicians are in short supply.

London: The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart devices in patients as they faced safety and quality concerns ...

The CE mark suspension isn’t the first setback the Cardiosave intra-aortic balloon pumps have faced in recent months. In December, Getinge began a recall of the pumps that was ultimately given the FDA ...