Office of Emergency Medical Services
Department of Public Health
Commonwealth of Massachusetts
Notice: FDA announces Class I recall of HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller
Please see the U.S. Food and Drug Administration (FDA) website, at https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm560200.htm, for information regarding Abbott Thoradec’s recall of over 28,000 HeartMate II Left Ventricular Assist (LVAS) Pocket System Controllers manufactured between July 2012 and December 2016, and distributed through March 2017. This recall is due to a risk of patient death or injury during backup controller exchange. Abbott-Thoratec has received a total of 70 reports of incidents, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital.
Customers with additional questions about this recall may contact Abbott's Heartline at: 800-456-1477.