Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with Recalled by Medtronic Xomed, Inc. Due to Potential for false negative response on the NIM...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Xomed, Inc. directly.
Affected Products
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
Quantity: 7,804 units
Why Was This Recalled?
Potential for false negative response on the NIM Vital Nerve Monitoring System
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Xomed, Inc.
Medtronic Xomed, Inc. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report