Thoratec Corp. is recalling 4,842 units of the HeartMate System Monitor because the screen may exhibit atypical behavior such as freezing, displaying distorted text, or showing zeroes instead of actual values. These malfunctions can cause buttons to become unresponsive or lead to the accidental selection of the 'Pump Stop' command, which is critical for patients using this heart assist device. The recall affects several models including REF 1286, L1286, 1286A, and others listed in the product details. Consumers should contact their healthcare provider or the manufacturer immediately if they experience any issues with the monitor screen.
A frozen or unresponsive screen can prevent medical staff or patients from controlling the heart pump, potentially leading to accidental pump shutoff or delayed medical procedures. This poses a significant risk of hemodynamic compromise, which is a dangerous drop in blood flow that can cause serious injury or death.
Manufacturer notification and guidance
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.