Recall Z-1731-2015 ยท DSQ Ventricular (Assist) Bypass
HeartWare Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP 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.
| Date | Jun 13, 2015 (initiated Apr 29, 2015) |
| Status | Open, Classified |
| Reason | Complaints with the HVAD Internal Controller Alarm Battery failures. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction letters were sent to customers. The letter identified the affected product, as well as the reason for the recall and risks involved. HeartWare requests that customers review and familiarize themselves with the letter and "Patient Communication," and ensure that all necessary individuals are aware. Patients currently being supported by the device should be identified and given the "Patient Communication." A HeartWare representative can provide assistance with that process if needed. The "Acknowledgement and Completion Form" should be completed, signed, and |
| Quantity | 3,747 curently implanted |
| Distribution | Worldwide Distribution -- US, including the states of 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; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denm |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.