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Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System
Recalled March 16, 2022 · FDA recall Z-0726-2022 · Heartware
Hazard
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. · FDA Class II
Units
197,889 units
Sold at
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 (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Description
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.
Product
HeartWare Ventricular Assist Device (HVAD) System
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →