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.
FDA tells healthcare facilities to avoid using two Getinge heart devices due to safety concerns. Company halts promotion & sales until quality issues are fixed.
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
The FDA is instructing healthcare facilities to avoid using two heart devices from Getinge amid concerns that the company has not adequately resolved issues that spurred a string of recalls over the ...
The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart ...
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 ...
Initiated by Abbott/Thoratec and deemed Class I by the FDA, the recall is in response to reports of 70 injuries and two ...
Following 12 company recalls and nearly 3,000 reported issues related to its cardiovascular life support systems since January 2023, Getinge has now drawn more scrutiny from the FDA — as the ...
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.
The US Food and Drug Administration (FDA) has tagged a recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) as Class I, the most serious designation for a medical device.
May 8 (Reuters) - The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's (GETIb.ST) , opens new tab heart devices in patients as ...