Heartware, Inc. recalls HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with a…

Recall date

January 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1427-2020

FDA classification

Class I

Brand / firm

Heartware, Inc.

Sold / distributed

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 o…

Why it was recalled

Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.