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Heartware, Inc. recalls HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients wit
Recalled March 18, 2020 · FDA recall Z-1427-2020 · Heartware
Hazard
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. · FDA Class I
Units
5,489 devices total
Sold at
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.
Description
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Product
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.
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →