HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of…

Recall date

April 29, 2015

Source

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

Recall number

Z-1751-2015

FDA classification

Class II

Brand / firm

HeartWare Inc

Sold / distributed

AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA, Foreign: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary,…

Why it was recalled

Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.