Medtronic Xomed, Inc. has recalled approximately 7,804 NIM Vital Nerve Monitoring systems because the devices may provide false negative responses during surgical procedures. A false negative occurs when the monitor fails to alert the surgeon of nerve activity, which can lead to unintentional nerve damage. These consoles, patient interfaces, and software versions were distributed worldwide, including throughout the United States. Consumers and healthcare facilities should contact their healthcare provider or Medtronic for instructions on how to handle affected equipment.
If the system provides a false negative, it fails to alert surgeons when nerves are being touched or irritated during surgery. This can result in surgeons accidentally damaging or severing nerves, which can lead to permanent muscle weakness, loss of sensation, or paralysis.
Manufacturer instructions for medical device safety
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.
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Sources: FDA iRES · Raw API Response
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