Recall Z-0005-2017 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
HeartWare Ventricular Assist System 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 HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
| Date | Oct 17, 2016 (initiated Jun 8, 2016) |
| Status | Terminated |
| Reason | Loose connector ports in controller body. |
| Root cause | Device Design |
| Action | HeartWare sent an Urgent Medical Device Correction letter dated June 8, 2016, to all affected customers, HeartWare advised clinicians to remind patients to follow unit instructions and water avoidance, and to regularly schedule appointments to check the integrity of the unit and to be cautious with connectors when inspecting connectors. Clinicians were also instructed to send back the enclosed "Acknowledgement Form" within 30 days and to forward the message to necessary individuals within their organization. Customers with questions were instructed to contact their local HeartWare representati |
| Quantity | 4235 Worldwide, 7272 units in U.S. |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, 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 countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.