FDA-Device2022-03-16Class II
HeartWare Ventricular Assist Device (HVAD) System
Heartware, Inc.
Hazard
Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
Sold states
Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Affected count
197,889 units
Manufactured in
14400 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
HeartWare Ventricular Assist Device (HVAD) System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2022Don't want to check this manually?
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