HeartWare Inc recalls HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-card

Recalled May 21, 2014 · FDA recall Z-1607-2014 · HeartWare

Hazard

Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced. · FDA Class II

Units

32,349

Sold at

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.

Description

Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.

Product

HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

Manufacturer(s)

HeartWare Inc

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