Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss
Medtronic Xomed is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss from the electrode.
What this means for you
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: The recall involves a medical device used during surgery where a malfunction (signal loss) could cause delays in the procedure. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medtronic Xomed, Inc. is recalling 53 units of the Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces, specifically the REF 8253410 (Neuro) model. The recall was initiated in January 2010 after the manufacturer identified a trend of open channel conditions, which result in signal loss from the electrode. The NIM 3.0 is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
When the device detects signal loss from the electrode, it fails the electrode check and provides an audible and visual warning to the user. This malfunction could create a delay in the surgical procedure. The affected units were distributed worldwide, including the United States and numerous international markets such as Australia, Canada, and various European and Asian countries.
Healthcare facilities and users should stop using the affected Medtronic NIM 3.0 Patient Interfaces immediately. Medtronic Xomed, Inc. is the recalling firm responsible for managing the recall. Users should contact the manufacturer for further instructions on how to proceed with the recall.
The recalled product
- Product
- Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 US
- Manufacturer
- Medtronic Xomed, Inc.
- Affected units
- 53
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 (1)
- 8253410 (Neuro). All Serial Numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Xomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Medtronic Xomed, Inc.
See all →- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighMedtronic NIM Vital Nerve Monitoring System Software Version Recall
FDA (Devices) · 2025-04-30
- HighMedtronic ENT Surgical Cutting Bur Distributed Past Expiration Date
FDA (Devices) · 2024-09-18
- SevereNIM Vital Nerve Monitoring Systems Recalled for False Negative Risk
FDA (Devices) · 2024-07-31
- HighNIM TriVantage EMG Endotracheal Tubes Recalled for Loss of Nerve Monitoring
FDA (Devices) · 2024-01-17
Same hazard · signal loss
See all →- HighDexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts
FDA (Devices) · 2026-05-20
- CriticalImpella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- HighMedtronic Invos Infant Sensor Cables recalled for manufacturing defects
FDA (Devices) · 2024-05-08
- HighFreeStyle Libre 3 App may lose signal on Android 13 devices
FDA (Devices) · 2024-01-24
- High