Reports of Injuries, Deaths Prompt FDA to Recall Heart Failure Devices
The HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, are now under a strict U.S. Food and Drug Administration recall after being tied to 273 known injuries and 14 deaths, the agency said Tuesday. However, as of now the two devices are not being removed from the market.
“The HeartMate II and 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure,” the FDA explained in a statement. “It can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant isn’t an option.”
Source: Advances and More licensed by HealthDay
