Medtronic Xomed, Inc. is recalling 9,788 units of the NIM Vital Nerve Monitoring System, including consoles, patient interfaces, and software upgrades (versions 1.4.3, 1.5.4, and 1.6.4). The recall is due to a software defect that can cause an increase in electrical interference or "stimulus artifact" during surgery. This issue can make it difficult for surgical teams to monitor nerves effectively, potentially requiring troubleshooting and causing procedure delays. In some cases, this defect could lead to serious medical complications, such as unplanned removal of a breathing tube (extubation) or the need for additional medical intervention. The affected systems were distributed nationwide and internationally to hospitals and surgical centers.
The software defect causes increased electrical interference that can disrupt critical nerve monitoring during surgical procedures. This interference may lead to surgical delays, unplanned medical interventions, or risks associated with anesthesia and airway management, such as accidental extubation.
All NIM Vital Nerve Monitoring Systems manufactured or installed with software version v1.6.4 or earlier.
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
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