Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System

Recall date

January 27, 2022

Source

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

Recall number

Z-0726-2022

FDA classification

Class II

Brand / firm

Heartware, Inc.

Sold / distributed

Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (So…

Why it was recalled

Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartWare Ventricular Assist Device (HVAD) System