Abbott and its subsidiary Thoratec Corp. warned customers of 13,883 heart devices after receiving reports of 273 injuries and 14 deaths related to blood flow obstructions.
Thoratec's HeartMate II and HeartMate 3 Left Ventricular Assist Systems help the heart pump blood, and they are used for patients with severe left ventricular heart failure. The devices 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," the FDA said April 15.
In February, Abbott and Thoratec sent letters to customers about the risk of extrinsic outflow graft obstruction, which is when biological material builds and potentially obstructs the device.
This buildup can happen over two years and result in serious adverse events or death, the FDA said.
The devices are not being removed from the market, but the FDA classified the warning as a Class I recall because of the health risks. Customers are asked to watch for low flow alarms and return Thoratec's urgent medical device correction letter with a completed acknowledgement form.