Heartware, Inc. recalls HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patient…

Recall date

June 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0005-2017

FDA classification

Class I

Brand / firm

Heartware, Inc.

Sold / distributed

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…

Why it was recalled

Loose connector ports in controller body.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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