The Class I recall is the second one for Abbott’s HeartMate 3 device this year and follows 70 injuries and two patient deaths ...
Abbott’s research has shown that its HeartMate 3 pump can extend the lives of advanced heart patients by at least five years.
The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart ...
May 8 (Reuters) - The U.S Food and Drug Administration ... opens new tab heart devices in patients as they faced safety and quality concerns despite a string of recalls. The recommendation ...
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
STOCKHOLM--Getinge shares trade at the bottom of the Stoxx Europe 600 index after the U.S. Food and Drug Administration advised healthcare providers to move away from using the Swedish company's heart ...
In a statement Wednesday, the FDA said it recommended providers find alternatives to Getinge's balloon pump and bypass devices ... to the heart's left ventricle. Eight of the recalls fall within ...
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
London: The U.S Food and Drug Administration ... away from using Getinge's heart devices in patients as they faced safety and quality concerns despite a string of recalls. The recommendation ...