Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss
Medtronic is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss and potential surgical delays.
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 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Xomed, Inc. is recalling 464 units of the Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces. The affected units include REF 8253200 (Response), 8253210 (Pulse), and 8253410 (Neuro). These devices are intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
The recall was initiated in January 2010 after Medtronic identified a trend of open channel conditions, which result in signal loss from the electrode. When the device detects this signal loss, 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 nationwide in the United States and in numerous other countries such as Australia, Canada, Germany, Japan, and the United Kingdom. All serial numbers are subject to the recall. Users should stop using the affected devices and contact Medtronic for further instructions.
The recalled product
- Product
- Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA*
- Manufacturer
- Medtronic Xomed, Inc.
- Affected units
- 464
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)
- 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.
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