Recall Z-1887-2016 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, includi
| Date | Jul 8, 2016 (initiated Jan 7, 2016) |
| Status | Terminated |
| Reason | Heartware Ventricular Assist System Battery Cell experiencing premature depletion. |
| Root cause | Software design |
| Action | The firm, HeartWare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 7, 2016, to all their consignees informing them that of the HeartWare HVAD Battery recall (device exchange). The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Promptly complete the attached Acknowledgment Form and return it to HeartWare no later than 30 days from the date of this letter via email to HeartWare7786@stericycle.com or provide verbal Acknowledgement by calling Customer Service line , 1(844)491-7871; or fax to +1 (844)721-3044.. 2. Immediately iden |
| Quantity | 18, 631 |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.