Sterilmed, Inc. has recalled approximately 10 ACUSON AcuNav Diagnostic Ultrasound 8FR catheters because they were reprocessed beyond their validated safety cycles. This recall involves both catheters not intended for use with Siemens systems and those reprocessed for use with Siemens systems. Using these catheters may compromise their sterility or structural strength, which can lead to serious patient safety issues.
Reprocessing these devices too many times can cause the catheter to break during a procedure or fail to remain sterile. This poses a significant risk of infection, damage to blood vessels, or an embolism (a blood clot or air bubble that blocks a blood vessel).
Recall #: Z-0573-2026
Recall #: Z-0574-2026
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.