FDA-Device2022-08-24Class I
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Heartware, Inc.
Hazard
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.
Sold states
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.
Affected count
19616 batteries
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2022Don't want to check this manually?
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