FDA-Device2020-03-18Class I
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Heartware, Inc.
Hazard
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Sold states
No affected devices distributed within the US. International distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, EGYPT, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Taiwan, Province of China, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Affected count
5,489 devices total
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1427-2020Don't want to check this manually?
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