Lower riskMedical device recall · FDA · Published March 10, 2025
Medtronic Xomed NIM Vital Nerve Monitoring System: Software Versions May Cause Procedure
Medtronic Xomed recalls NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased nerve monitoring artifacts, which may cause procedure delays and medical interventions.
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.
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📍Recalling firmMedtronic Xomed, Inc.6743 Southpoint Dr N · Jacksonville, FL 32216-6218
✎ GovInfoNow plain-language explainer
Medtronic Xomed is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier. These systems may cause increased nerve monitoring artifacts, leading to procedure delays and medical interventions. Affected users should check their software version and contact Medtronic for updates. Read more at govinfonow.com/recall/52653-medtronic-xomed-nim-vital-nerve-monitoring-system-software-versions-may.
“Medtronic Xomed NIM Vital Nerve Monitoring System: Software Versions May Cause Procedure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52653-medtronic-xomed-nim-vital-nerve-monitoring-system-software-versions-may. Based on FDA recall #Z-1623-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1623-2025%22&limit=1).
The FDA announced on March 10, 2025, that Medtronic Xomed, Inc. is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to a potential for increased stimulus artifact. This issue may require troubleshooting and could lead to procedure delays, extubation, and medical intervention.
How to tell if you have it
CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01
CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF
PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1
PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF
The nerve monitoring system with certain software versions has the potential for increased stimulus artifact, which may require troubleshooting and may lead to procedure delay, extubation, and medical intervention.
Context
GovInfoNow's records show Medtronic Xomed, Inc. has 11 other recalls on record since November 13, 2019. Other recent recalls of similar products include Medtronic Xomed NIM Vital Nerve Monitoring Systems: False Negative Risk (June 24, 2024) and Medtronic Vanta CP App Software Recall (December 3, 2025).
How to tell if you have this one
Check for the console model NIM4CM01 or NIM4CM01RF, patient interface NIM4CPB1 or NIM4CPB1RF, or software versions v1.6.4 or earlier. The product was sold with specific reference numbers listed in the recall notice.
Brand
Medtronic Xomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Review the software version on your NIM Vital Nerve Monitoring System to determine if it is v1.6.4 or earlier.
Contact Medtronic
Reach out to Medtronic Xomed for guidance on updating the software or other remedies.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1623-2025 (March 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1623-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.