HeartWare Ventricular Assist System recalled over foreign material

Recall date

August 17, 2016

Source

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

Official notice title

HeartWare, Inc recalls HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX.…

Recall number

Z-0006-2017

FDA classification

Class I

Brand / firm

HeartWare, Inc

Sold / distributed

Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Leb…

Why it was recalled

Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.

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), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.