Medtronic NIM Vital Nerve Monitoring System Software Version Recall
Medtronic is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased stimulus artifact that may require troubleshooting and could lead to procedure delay, extubation, and medical intervention.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with potential for patient harm (procedure delay, extubation, need for medical intervention). The source text does not explicitly state that illnesses or injuries have been reported, and the hazard is characterized as a "potential" technical issue. Under the rubric, high-risk medical devices where risk of harm exists but injury has not yet been reported score 3.
Plain-English summary
Medtronic Xomed, Inc. is recalling the NIM Vital Nerve Monitoring System, including Console models NIM4CM01 and NIM4CM01RF, Patient Interface models NIM4CPB1 and NIM4CPB1RF, and Software upgrades NIM4SWU143, NIM4SWU154, and NIM4SWU164. The recall affects units manufactured or installed with software version v1.6.4 or earlier. Approximately 9,788 units are affected.
The systems have a potential for increased stimulus artifact, which may require troubleshooting. This technical issue may lead to procedure delay, extubation (removal of breathing tube), and medical intervention.
The NIM Vital Nerve Monitoring System has been distributed worldwide, including throughout all 50 US states and numerous international countries. Facilities using these systems should contact Medtronic Xomed, Inc. for instructions on addressing this issue. Users should review the recall notice and follow any corrective actions recommended by the manufacturer.
The recalled product
- Product
- NIM Vital Nerve Monitoring System: 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; SOFTWARE NIM4SWU143…
- Manufacturer
- Medtronic Xomed, Inc.
- Affected units
- 9,788
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 00763000395896
- 00763000401597
- 00763000528577
- NIM4CM01RF/00763000002992
- NIM4CPB1/763000002985
- 00763000401603
- 00763000395902
- 00763000528584
- NIM4CPB1RF/00763000003005
- NIM4SWU143/00763000709341
- 00763000869823
- NIM4SWU154/00763000945398
- NIM4SWU164/00763000974312
Distribution
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