Recall Z-1471-2014 ยท DSQ Ventricular (Assist) Bypass
HeartWare Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. 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 VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or he
| Date | Apr 23, 2014 (initiated Dec 6, 2013) |
| Status | Terminated |
| Reason | The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. |
| Root cause | Process control |
| Action | HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their hospitals and doctors on December 12, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. For already implanted patients, arrange a follow up visit at the earliest convenience to check patient's driveline connector. They were asked to sign and return the Acknowledgement Form to HeartWare. For questions, contact your HeartWare Representative or HeartWare Customer Service at 1-877-367-4823. |
| Quantity | 4,586 |
| Distribution | Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.