Medtronic Recalls NIM 3.0 Patient Interfaces Due to Signal Loss
Medtronic Xomed is recalling seven NIM 3.0 Patient Interfaces because they may fail to detect electrode signal loss, potentially delaying surgical procedures.
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 where a malfunction (signal loss) could delay a surgical procedure, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Medtronic Xomed, Inc. is recalling seven units of the Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces, specifically REF 8253210 (Pulse). The affected units are identified by serial numbers 00004, 00009, 00010, 00013, 00014, 00015, and 00017. These devices are intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery.
The recall was initiated after Medtronic identified a trend of open channel conditions, which involve signal loss from the electrode. When the NIM 3.0 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 in the United States and numerous international countries. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 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
- 7
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 (7)
- 8253210 (Pulse). Serial Numbers 00004
- 00009
- 00010
- 00013
- 00014
- 00015
- 00017 (International Consignees only)
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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