Recall Z-1538-2017 ยท DSQ Ventricular (Assist) Bypass
Heartware
HeartWare HVAD System Controller 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. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
| Date | Feb 3, 2017 |
| Status | Open, Classified |
| Reason | Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0) |
| Root cause | Software design |
| Action | The firm will release a communication to their consignees stating the following: As a reminder, as with all HVAD Controllers, continue to reinforce the following with your patients and staff at all opportunities: " Patients should continue to have a backup HVAD Controller ready at all times in the event of a primary HVAD Controller failure. " Staff only: The driveline extension cable is to be used during the pre-implant test only. It is not intended to be used after the pump is implanted in the patient. Hospital and Clinician Actions (to be executed in the following order): 1) Review the encl |
| Quantity | 8,343 US and 13,145 INTERNATIONAL |
| Distribution | Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.