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HeartWare Inc recalls Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Recalled August 7, 2013 · FDA recall Z-1813-2013 · HeartWare
Hazard
Potential to electrostatic discharged (ESD) · FDA Class II
Units
76 (US) and 82 (International)
Sold at
Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Description
Potential to electrostatic discharged (ESD)
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Manufacturer(s)
HeartWare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →