Recalled NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with specific software versions v1.0.0, v1.1.1, v1.3.2, v1.4.3 may show false negative responses. Consumers should check their product details.
Potential for false negative response on the NIM Vital Nerve Monitoring System
Medtronic Xomed is recalling all NIM Vital Nerve Monitoring systems with specific software versions (v1.0.0, v1.1.1, v1.3.2, v1.4.3) that could show false negative responses. This means the system might not detect nerve issues properly, which could lead to missed medical conditions. Read more at govinfonow.com/recall/54776-medtronic-xomed-nim-vital-nerve-monitoring-systems-false-negative-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/54776-medtronic-xomed-nim-vital-nerve-monitoring-systems-false-negative-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2409-2024
“Medtronic Xomed NIM Vital Nerve Monitoring Systems: False Negative Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54776-medtronic-xomed-nim-vital-nerve-monitoring-systems-false-negative-risk. Based on FDA recall #Z-2409-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2409-2024%22&limit=1).
The FDA is overseeing a voluntary Class I recall initiated by Medtronic Xomed, Inc. involving NIM Vital Nerve Monitoring systems due to potential software issues.
Certain software versions (v1.0.0, v1.1.1) may cause increased stimulus artifact, requiring troubleshooting, leading to procedure delays, extubation, or medical intervention.
Medtronic Xomed, Inc. has 11 other recalls on record since November 13, 2019.
Check if your NIM Vital Nerve Monitoring system has software versions v1.0.0, v1.1.1, v1.3.2, or v1.4.3. Look for product models including NIM4CM01, NIM4CM01RF, NIM4CPB1, or NIM4CPB1RF.
Identify your NIM Vital Nerve Monitoring system's software version and model number to see if it matches the recalled versions.
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
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.