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

Recalled June 17, 2015 · FDA recall Z-1698-2015 · HeartWare

Hazard

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

Units

3,747 currently implanted worldwide

Sold at

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, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.

Description

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

Product

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.

Manufacturer(s)

HeartWare Inc

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