HeartWare Inc - HeartWare Ventricular Assist System - Class 1 Recall

HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=133229

Source: Medical Device Recalls - February 26, 2015 Category: Medical Equipment Source Type: alerts