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Heartware, Inc. recalls HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in pat
Recalled October 26, 2016 · FDA recall Z-0005-2017 · Heartware
Hazard
Loose connector ports in controller body. · FDA Class I
Units
4235 Worldwide, 7272 units in U.S.
Sold at
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.
Description
Loose connector ports in controller body.
Product
HeartWare Ventricular Assist System Controller Product Usage: 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 HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →