Device product
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.
Z-1420-2013
Product summary
- Event
- Event 64631
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,591 units
- Official record key
device-enforcement:Z-1420-2013
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.
Derived failure modes
-
Unknown
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.