HeartWare Ventricular Assist Device (HVAD) System
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.
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.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2022