Recall Z-1131-2015 ยท DSQ Ventricular (Assist) Bypass
HeartWare Inc
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.
| Date | Feb 25, 2015 (initiated Jan 16, 2015) |
| Status | Terminated |
| Reason | The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers. |
| Root cause | Device Design |
| Action | HeartWare sent an URGENT MEDICAL DEVICE RECALL dated January 16, 2015 asking clinicians to quarantine the affected controllers and complete and return the acknowledgement form. HeartWare also asks clinicians to identify patients with affected controllers and review the applicable risks with the patient and as soon as reasonably possible if medically advisable, exchange the affected controller under medical supervision with a new controller. HeartWare also asks that for each patient using an affected controller as their backup to contact the patient and arrange to have the backup controller r |
| Quantity | 4,845 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.