NIM Vital Nerve Monitoring Systems Recalled for False Negative Risk
Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The potential for false negative responses in a nerve monitoring device creates serious patient safety risk by allowing undetected nerve damage to go unnoticed, even though no injuries or deaths have been reported to date.
Plain-English summary
Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems, including NIM 4.0 console units (models NIM4CM01 and NIM4CM01RF), patient interface devices (models NIM4CPB1 and NIM4CPB1RF), and software upgrades. All units with NIM Vital System versions v1.0.0, v1.1.1, v1.3.2, and v1.4.3 are included in this Class I recall.
The systems may produce false negative responses, meaning they could fail to detect nerve damage or dysfunction when the device is being used to monitor nerve integrity.
Approximately 7,804 units have been distributed worldwide, including throughout the United States and to numerous other countries. These devices are used in healthcare settings where nerve monitoring is required.
Healthcare facilities and practitioners using these devices should contact Medtronic Xomed for instructions on device handling and replacement. The FDA classified this as a Class I recall due to the serious potential safety risk posed by the device's potential failure to detect nerve-related problems.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Xomed, Inc.
- Affected units
- 7,804
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 (20)
- All serial numbers manufactured) with NIM Vital System versions: v1.0.0
- v1.1.1
- v1.3.2
- v1.4.3. Product Number
- GTIN Number (Lot Number): 1. Product Number: NIM4CM01
- GTIN Number (Lot Number): 00763000002978 (1850076
- 1850079
- 1850082
- 1850083
- 1850093
- 1850095
- C1915008
- C1915009
- C1915012
- C1915013
- C1915014
- C1915015
- C1915018
- C1915020
- C1915022
Distribution
Distributed nationwide across the United States.
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