There have also been hundreds of injuries.
FDA: Heart Pumps Recalled after 14 Deaths
It’s the last thing any heart patient wants to hear; that their heart pump is being recalled.
‘ABC’ reports that “Abbott Laboratories’ Thoratec Corp. is recalling nearly 14,000 HeartMate II and HeartMate 3 Left Ventricular Assist Systems.”
The FDA says this is a Class I recall, the most serious type, after 14 deaths and 270 injuries have been allegedly caused by the devices.
A possible “build up of biological materials” could prevent the devices from pumping blood. The pumps have been used on both adults and children.
The company is asking any device recipients to measure low flow levels and to acknowledge the recall letter sent out in order to receive updates until “corrective measures” are in place.