Reported Jun 12, 2013 · Terminated

REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint…

Medtronic Xomed, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218

Is this the product you have?

  • REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
Lot codes and dates
  • Product Catalog Numbers
    • REF 8229705
    • 8229706
    • 8229707
    • 8229708
    • 8229709
    • 8229735
    • 8229736
    • 8229737
    • 8229738
    • 8229739
  • Lot Numbers
    • 205830052 to 206486732. 0206516104
    • 0206516105
    • 0206516106
    • 0206516108
    • 0206520224
    • 0206520225
    • 0206520226
    • 0206520227
    • 0206520228
    • 0206520358
    • 0206542163
    • 0206545356
    • 0206545502
Amount recalled
2,591 units

Where it was sold

Why it was recalled

Stop using this product now

In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 30, 2014 · Data as of Sep 19, 6:53 PM UTC

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