Company: Abbott-Thoratec
Date of Enforcement Report 5/23/2017
Class I:
PRODUCT
HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller
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 back-up 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.
Recall Number
REASON
Patients may sometimes need to change to their backup back-up 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 that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.
Abbott-Thoratec has received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital.
To address this issue, Abbott-Thoratec is providing all HeartMate II LVAS with Pocket Controller users with new software and hardware updates to assist patients in successfully changing their pocket controller in emergency situations.
RECALLING FIRM/MANUFACTURER
Abbott-Thoratec on 3/30/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
DISTRIBUTION
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