Z-1420-2013 Class I Terminated
FDA device recall Z-1420-2013 was initiated by Medtronic Xomed, Inc. on Mar 4, 2013 and is designated Class I. Reason for recall: 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… The recall status is terminated (terminated Jan 30, 2014). Affected quantity: 2,591 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2013
- Initiation Date
- Mar 4, 2013
- Termination Date
- Jan 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,591 units
Product Description
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.
Reason for Recall
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1420-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026