Field Safety Notice: HeartWare HVAD Controller Software, AC Adapter and Battery

vrijdag 22 januari 2016 14:00

As part of HeartWare’s ongoing product performance monitoring, we have reviewed certain complaints related to the HVAD® System and are distributing this notice to announce (i) the distribution of the previously disclosed software update for certain HVAD® Controllers intended to improve power management; (ii) a voluntary recall of AC Adaptors designed for 220-volt power grids; and (iii) a voluntary recall of certain older batteries more likely to exhibit deterioration of battery capacity.