The devices are used in patients undergoing cardiac and non-cardiac surgery, and to treat those who have had heart failure or ...
The FDA recently labeled a recall of Abbott (NYSE: ABT) + Abbott Laboratories $105.79 1.58% Open 107.32 Day High 107.32 52 ...
In March, Abbott recalled the Heartmate 3 system after a sealing issue during implant was tied to 70 injuries and two deaths. The company recalled Heartmate II and Heartmate 3 systems in February due ...
Recently, the FDA announced a Class I recall for Abbott’s HeartMate 3 left ventricular assist device (LVAD), an MCSD that helps a failing heart pump oxygenated blood throughout the body.
The company, along with its subsidiary Arrow International, recalled the devices after finding that a manufacturing error had ...
May 22 (Reuters) - The U.S. Food and Drug Administration on Wednesday classified a recall of Hologic's (HOLX.O) , opens new tab devices that are implanted in soft tissue such as breast tissue as ...
The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 database entry by the Food and Drug ... for heart failure patients. The device takes over ...
(Reuters) -The U.S. Food and Drug Administration on Wednesday classified a recall of Hologic's devices that are implanted in soft tissue such as breast tissue as "most serious", and urged doctors to ...
(Reuters) -The U.S. Food and Drug Administration on Wednesday classified a recall of Hologic's devices that are implanted in soft tissue such as breast tissue as "most serious", and urged doctors ...
FDA reports 322 complaints, 31 injuries and 3 deaths related to Teleflex and Arrow International's intra-aortic balloon pumps. Learn more about the recall here.
Hologic’s recall of its BioZorb Markers due to complications with the implanted device were recently identified as Class I by FDA after 71 injuries were reported as being related to BioZorb Markers.