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HeartWare Inc recalls HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplanta
Recalled March 4, 2015 · FDA recall Z-1131-2015 · HeartWare
Hazard
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers. · FDA Class I
Units
4,845
Sold at
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
Description
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Product
HeartWare Ventricular Assist System (HeartWare Controller) 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. The HeartWare System 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 →