Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

On 3/10/2025, recall notices were mailed, and/or emailed to customers who were asked to do the following: 1) Your Medtronic representative will contact you to install the new software version 1.7.5 for correction of the impacted product in your possession. 2) For patients who are currently being monitored with affected devices, be aware of the possibility of increased stimulus artifact. Refer to the system instructions for use for instructions on how the stimulus artifact may be reduced or exacerbated through the adjustment of system settings including event threshold, stimulation current, and rejection period. 3) Complete and return the customer confirmation form via email to neuro.quality@medtronic.com 4) Share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for your records. Distributors are asked to discard any of the items below in your inventory: a. SOFTWARE NIM4SWU143 UPGRADE v1.4.3 b. SOFTWARE NIM4SWU154 UPGRADE v1.5.4 c. SOFTWARE NIM4SWU164 UPGRADE v1.6.4 If you have any questions regarding this communication, please contact the firm's Sales Representative or Technical Services at 1-888-826-5603.

• FDA enforcement recordOfficial FDA database entry for Z-1623-2025
• FDA 510(k) clearance · K200759The device's official FDA premarket clearance record
• FDA device classification · GWFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.1870The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic Xomed, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.