Abbott Laboratories and the Thoratec Corporation have recalled the HeartMate II LVAS Pocket System Controller because of a risk of patient injury and/or death during backup controller exchange. Twenty-six deaths have occurred when patients attempted to exchange controllers outside of the hospital.
The FDA has identified this as a class I recall, the most serious type of recall. Nearly 29,000 devices have been pulled from the market nationwide.
The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. The controller is powered by batteries or connected to a main power supply.
The HeartMate II LVAS Pocket System Controller is intended for use inside or outside of the hospital. A backup system controller is provided to each patient for use in case of a device alarm or malfunction. Instructions and training are provided on how to switch from one system controller to the other.
Patients may sometimes need to change to their backup system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital because it can present a significant challenge to patients who are elderly and/or untrained, according to the FDA. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.
Abbott and Thoratec have received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 26 deaths and 19 injuries.
On March 29, 2017, Abbott and Thoratec sent an Urgent Medical Device Correction letter to affected customers. The letter identified the following actions to be taken:
Source: FDA; May 23, 2017.