![]() It is not intended to be used after the pump is implanted in the patient. " Staff only: The driveline extension cable is to be used during the pre-implant test only. " Patients should continue to have a backup HVAD Controller ready at all times in the event of a primary HVAD Controller failure. The firm will release a communication to their consignees stating the following:Īs a reminder, as with all HVAD Controllers, continue to reinforce the following with your patients and staff at all opportunities: Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0) HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter ![]() The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Ventricular (assisst) bypass - Product Code DSQ ![]() Class 1 Device Recall HeartWare Ventricular Assist System ![]()
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