Thoratec LLC is recalling approximately 67,107 HeartMate 3 and HeartMate II Left Ventricular Assist Systems (LVAS) and standalone controllers. The devices are being recalled because of potential corrosion in the Backup Battery cable connector, which can trigger a "Backup Battery Fault" alarm. If this alarm occurs, the backup battery may not provide necessary power during a main power failure, potentially causing the heart pump to stop and leading to serious health complications or death.
Corrosion in the backup battery connector can prevent the system from switching to emergency power if the primary power source is lost. This malfunction could cause the heart pump to stop, which is life-threatening for patients dependent on the device for cardiac support.
Quantity: 29,059 units. Note: Backup battery has a 3-year life cycle and can be replaced per instructions.
Quantity: 35,376 units. Central power and communication hub for the HeartMate 3 LVAS.
Quantity: 248 units. Axial-flow rotary ventricular assist system.
Quantity: 2,424 units. Small computer that monitors and controls pump operation.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.