(NEXSTAR) — The Food and Drug Administration (FDA) announced Monday that two heart pump products are being recalled after reports of 14 deaths and hundreds of injuries were associated with the devices.
Abbott Laboratories’ Thoratec Corp. is recalling 13,883 HeartMate II and HeartMate 3 Left Ventricular Assist Systems according to the Class I recall, which the FDA says is the most serious type.
The heart pumps, which are used to save the lives of patients with failing hearts by helping it circulate blood throughout the body, were first distributed April 21, 2008. While both devices have been given to adults, the HeartMate 3 can also be used in children.
The FDA says the HeartMate products are being recalled due to a possible buildup of “biological material” that can obstruct the device and keep it from properly pumping blood. The accumulation usually happens over two years or more.
“The use of affected LVAS may cause serious adverse health consequences and in worst cases, could result in death,” according to the FDA. “There have been 273 reported injuries and 14 reports of death associated with this issue.”
Thoratec Corporation is asking patients to pay attention to low flow alarms, which may mark the first symptom of significant blockage.
See a complete list of all affected HeartMate model numbers on the FDA website.
Thoratec said it also included additional details in an Urgent Medical Device Correction Letter to all affected patients Feb. 19, according to the FDA. Those who received a letter are asked to return the enclosed acknowledgement form so the company can send updates “until the corrective measures are in place.”
Anyone with further questions should call Abbott/Thoratec Corporation at (844) 692-6367.
