Medtronic Perfusion Systems is recalling 26 units of the Affinity NT Oxygenator (Product Number 541B). This device is used during surgery to provide oxygen to a patient's blood and remove carbon dioxide. The recall was issued after Medtronic found a unit with decreased carbon dioxide gas transfer rates that did not meet required performance standards.
If the device fails to effectively remove carbon dioxide from a patient's blood during surgery, it could lead to inadequate ventilation and potential patient harm requiring medical intervention.
Recall Number: Z-0487-2026
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.