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Heartware Inc recalls Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Recalled May 22, 2013 · FDA recall Z-1323-2013 · Heartware
Hazard
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector. · FDA Class II
Units
3,544
Sold at
Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.
Description
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
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 →