Inspire Medical Systems Inc. is recalling 609 units of the Inspire Model 4340 Respiratory Sensing Lead and Model 4063 Stimulation Lead, which are components of the Upper Airway Stimulation (UAS) system. The recall was initiated because of a labeling error where the serial number printed on the outside of the shelf box does not match the serial number of the actual lead inside the box. This mismatch can lead to incorrect medical record keeping or confusion during surgical procedures. Consumers should contact their healthcare provider or the manufacturer to determine if their specific implanted or inventory device is affected.
The mismatch between the box label and the device serial number may result in the wrong device information being recorded in a patient's medical history. This can cause complications during future medical procedures, troubleshooting, or follow-up care where accurate device identification is critical for patient safety.
Contact your healthcare provider or the manufacturer for further instructions and potential refund
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.