Device product
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, including transportation via fixed-wing aircraft or helicopter.
Z-1887-2016
Product summary
- Firm
- Heartware, Inc.
- Event
- Event 73636
- Status
- Terminated
- Classification
- Class I
- Quantity
- 18, 631
- Official record key
device-enforcement:Z-1887-2016
Official wording
Reason: Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Code information: Serial numbers ranging BAT000001 to BAT199999.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.