HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205.…

Recall date

April 29, 2015

Source

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

Recall number

Z-1698-2015

FDA classification

Class I

Brand / firm

HeartWare Inc

Sold / distributed

Worldwide Distribution - US Nationwide in the states of 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, VA and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Eg…

Why it was recalled

HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.

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 (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.