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

Recall date

April 29, 2015

Source

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

Recall number

Z-1731-2015

FDA classification

Class I

Brand / firm

HeartWare Inc

Sold / distributed

Worldwide Distribution -- US, including 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, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Den…

Why it was recalled

Complaints with the HVAD Internal Controller Alarm Battery failures.

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. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.