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Nerve Monitoring System Correction: Medtronic Issues Correction for NIM Vital Nerve Monitoring System due to the Potential for False Negative Response
Medtronic is correcting the NIM Vital Nerve Monitoring System product due to reports of false negative responses. This can occur during procedures, where the device may fail to issue an electromyography (EMG) tone when the NIM probe is placed on a nerve.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact their Medtronic Representative or Medtronic Customer Quality at RS.JaxProductQuality@medtronic.com.
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