FDA-Device2013-05-22Class II
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Heartware Inc
Hazard
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Sold states
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.
Affected count
3,544
Manufactured in
14000 NW 57th Ct, Miami Lakes, FL, United States
Products
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1323-2013Don't want to check this manually?
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