HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2022