American College of Cardiology18 día(s)
FDA Update: Abbott Recalls HeartMate 3 LVAS Implant Kit
The U.S. Food and Drug Administration (FDA) announced on May 15 that Abbott is recalling the HeartMate 3 Left Ventricular Assist System (LVAS) implant kit due to risk of blood leakage or air entering ...
Medindia9 día(s)
Recall of Artificial Heart Devices for Heart Transplant by FDA
Heart failure (HF) is a significant factor driving the growth of mechanical circulatory support devices (MCSDs), which are used in three therapies for patients not eligible for heart transplants ...
Yahoo Finance18 día(s)
FDA recalls Abbott’s HeartMate 3 ventricular assist device after 2 deaths
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.
FierceBiotech20 día(s)
FDA elevates cardiovascular catheter recalls from Boston Scientific, Route 92 Medical
FDA elevates cardiovascular catheter recalls from Boston Scientific, Route 92 Medical By Conor Hale May 14, 2024 12:15pm Boston Scientific Route 92 Medical cardiovascular disease Class I recall ...
medtechdive25 día(s)
FDA tells providers to stop using Getinge heart devices
The Food and Drug Administration in a letter Wednesday told healthcare providers and facilities they should stop using certain Getinge cardiovascular medical devices. Getinge has initiated 20 recalls ...
Morningstar24 día(s)
Getinge Shares Sink After FDA Warns on Heart Devices
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 ...
Reuters24 día(s)
US FDA advises healthcare facilities to switch from Getinge's heart devices
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 ...
Yahoo Finance26 día(s)
UPDATE 2-US FDA advises healthcare facilities to switch from Getinge's heart devices
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 ...
TCTMD26 día(s)
FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices
Certain cardiovascular devices made by Getinge/Maquet remain problematic and should be avoided if possible, the US Food and Drug Administration said Wednesday in a letter to healthcare providers. The ...
Becker's Hospital Review25 día(s)
48 injuries, deaths tied to Getinge heart devices: FDA
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 ...
medtechdive18 día(s)
Getinge to limit US sales of heart devices after FDA safety warning
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 ...