Following 70 reports of device incidents that resulted in 19 injuries and 26 deaths, Abbott-Thoratec is recalling its HeartMate II LVAS system. The mechanical device circulates blood throughout the body when the heart cannot adequately pump blood on its own. However, the product issue stems from a malfunction that occurs when patients change to their backup-system controller during ventricular assist therapy. This change is supposed to occur in the hospital, because it can be a difficult task for patients (i.e., a slow or improper lead changeover); all of the deaths occurred when patients tried to exchange the controller out of the hospital environment.
How the Controller Works
The Heartmate II’s pocket system controller is a power supply that connects to the implantable pump via a lead under the skin. Either powered by batteries or connected to a power supply, the controller helps power the LVAS system. It can be used both inside and outside of the hospital, and each patient is given a back-up system controller to be used when a device alarm or malfunction occurs.
The recall affects certain models manufactured from July 2012 to December 2016. On March 29, Abbott-Thoratec sent affected customers an Urgent Medical Device correction letter stating that patients would receive upgraded hardware and software.
An Abbott spokeperson stated in an email, “No products are being retrieved in this case; rather, the focus is on communication to physicians so they can ensure their patients have their controller exchange completed in a clinical setting. We have also updated our software and controller alerts to help patients connect with their physician’s office when they need to have their controller exchanged.”