Recall Z-1751-2015 ยท DSQ Ventricular (Assist) Bypass
HeartWare Inc
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
| Date | Jun 10, 2015 (initiated Apr 29, 2015) |
| Status | Open, Classified |
| Reason | Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. |
| Root cause | Device Design |
| Quantity | 3,747 currently in use |
| Distribution | AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA, Foreign: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.