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HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of
Recalled June 17, 2015 · FDA recall Z-1751-2015 · HeartWare
Hazard
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. · FDA Class II
Units
3,747 currently in use
Sold at
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, Foreign: 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, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK,
Description
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
Product
HeartWare Ventricular Assist System (HVAD) 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 →