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 FDA calls this "the most serious type of recall," alerting healthcare providers as well as patients about these products ...
FDA tells healthcare facilities to avoid using two Getinge heart devices due to safety concerns. Company halts promotion & sales until quality issues are fixed.
Medtronic stopped selling what heart device after a series of recalls and mounting evidence concerning safety?
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart ...
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 ...
Initiated by Abbott/Thoratec and deemed Class I by the FDA, the recall is in response to reports of 70 injuries and two ...
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 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.
May 8 (Reuters) - 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 ...