After the FDA instructed healthcare facilities to avoid using two Getinge heart devices because of quality ... After numerous recalls and corrections, the FDA said it is still receiving reports ...
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.
Initiated by Abbott/Thoratec and deemed Class I by the FDA, the recall is in response to reports of 70 injuries and two ...
the FDA said. The problem impacts the integrity of the blood flow and may lead to longer-than-expected surgery, hemorrhage, right heart failure or air embolism. The agency said 882 devices ...
Last week, the FDA advised providers against using Getinge’s Cardiosave intra-aortic balloon pumps and Cardiohelp cardiopulmonary bypass systems after seeing the company start 20 recalls of the ...
The seal break allows for blood or air to enter the device which can result in bleeding, right heart failure ... I by the agency in September 2023. "FDA recalls Abbott’s HeartMate 3 ventricular ...
opens new tab will limit sales of some of its heart products in the U.S ... from the U.S. Food and Drug Administration (FDA) to move away from its devices. "We have decided to immediately ...
This is a Class I recall, which is “the most serious type of recall,” the FDA said in a statement. “Use of these devices may cause serious injuries or death.” Here’s what you need to ...
(Reuters) - Sweden's Getinge will limit sales of some of its heart products in the ... the U.S. Food and Drug Administration (FDA) to move away from its devices. "We have decided to immediately ...
(Reuters) - Sweden's Getinge will limit sales of some of its heart products in the U.S., the medical equipment maker said late on Tuesday, after recent advice from the U.S. Food and Drug ...
STOCKHOLM--Getinge shares are under pressure Wednesday after the company said it will limit sales of some of its heart devices in the ... the recent blows from the FDA and the fact that 2028 ...