The recall affects the only medical option for many patients with end-stage heart failure who do not qualify for a transplant ...
The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by ...
Federal health officials said that nearly 14,000 heart devices tied to hundreds of injuries and more than a dozen deaths are ...
The FDA has issued a recall of Abbott's Thoratec heart pumps due to reports of 273 injuries and 14 deaths linked to the ...
The FDA says the products are being recalled due to a possible buildup of "biological material" that can obstruct the device.
Biological material can build up and obstruct blood flow in heart failure patients supported by the left ventricular assist devices, the FDA said.
The devices have been recalled due to extrinsic outflow graft obstruction, which occurs when biological material builds up.
The FDA calls it "the most serious type of recall," alerting healthcare providers and patients about these products ...
Initiated by Abbott/Thoratec and deemed Class I by the FDA, the recall is a response to reports of 273 injuries and 14 deaths ...
WEDNESDAY, April 17, 2024 (HealthDay News) -- Two implanted heart devices used by patients in end-stage heart failure are now ...
The Food and Drug Administration (FDA) recently announced that two heart devices, the HeartMate II and HeartMate 3 Left ...
The FDA announced Monday that two heart pump products are being recalled after reports of 14 deaths and hundreds of injuries ...