Heartware, Inc. recalls HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-

Recalled July 20, 2016 · FDA recall Z-1887-2016 · Heartware

Hazard

Heartware Ventricular Assist System Battery Cell experiencing premature depletion. · FDA Class I

Units

18, 631

Sold at

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.

Description

Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

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.

Manufacturer(s)

Heartware, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →