Heartware, Inc. is recalling approximately 19,425 HVAD (HeartWare Ventricular Assist Device) systems due to necessary updates for the system's instructions for use and patient manual. These updates are required to clarify the specific conditions under which a [Controller Fault] alarm may sound and to provide clear troubleshooting steps for patients and healthcare providers. The recall also addresses revised instructions concerning the useful life of various system components to ensure the device continues to function safely. These devices were manufactured in the United States and distributed worldwide.
If the instructions for managing a [Controller Fault] alarm are not clearly understood, or if system components are used beyond their intended useful life, there is a risk of device failure or loss of pump support. This could lead to serious medical complications, including heart failure symptoms, blood clots, or death.
Instruction for Use (IFU) and Patient Manual (PM) Updates
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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