Brand name recallZ-0310-05 · Medtronic Xomed, Inc. · initiated Oct 29, 2004
Terminated All recalls posted in December 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Xomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
FDA root cause category: Other
Recall details
- Recall number
- Z-0310-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 29, 2004
- Posted by the FDA
- Dec 15, 2004
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 22569 EMG Tubes
- Product code
- ETN
- FDA submissions
- K925640
- Distribution
- Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
Product description
Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [All products are packaged one unit per box.]
Code information (models, lots, serial numbers)
Product Code: 77 ETN Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400
Other devices under the same FDA submission
12 devices cleared under K925640 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall29 reports
- NIM® 8229308Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall13 reports
- NIM 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall11 reports
- NIM 8229308Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall2 reports
- NIM FLEX™ 8229970Medtronic Xomed, Inc. · STIMULATOR, NERVE11 reports
- NIM FLEX™ 8229975Medtronic Xomed, Inc. · STIMULATOR, NERVE8 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE2 reports
- NIM FLEX™ 8229965Medtronic Xomed, Inc. · STIMULATOR, NERVE2 reports
- NIM FLEX™ 8229980Medtronic Xomed, Inc. · STIMULATOR, NERVE2 reports
- NIM FLEX™ 8229985Medtronic Xomed, Inc. · STIMULATOR, NERVE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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