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U.S. Department of Health and Human Services

Class 1 Device Recall NIM TriVantage EMG Endotracheal Tube

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 Class 1 Recall
NIM TriVantage EMG Endotracheal Tube
see related information
Date Posted June 04, 2013
Recall Status1 Terminated on January 30, 2014
Recall Number Z-1420-2013
Recall Event ID 64631
Premarket Notification
510(K) Number
K112686 
Product Classification Stimulator, Nerve - Product Code ETN
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.
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.
Recalling Firm/
Manufacturer
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville, Florida 32216-6218
For Additional Information Contact Gabriela Anchondo
904-279-7550
Manufacturer 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.
FDA Determined
Cause 2
TRAINING: Use Error
Action The firm, Medtronic Xomed, Inc. sent an "URGENT Product Recall Notification" letter dated March 14, 2013, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to return any affected devices still in their possession per the following procedure: 1. Check inventories for the affected products listed on the enclosed checklist. 2. Fill-in the "quantity on-hand" column on the checklist. 3. Fax checklist to Medtronic ENT at 1-904-296-2386. 4. If you have any of the subject product, contact Medtronic ENT Customer Service at 1-800-874-5797 to arrange for returns and replacement or credit. 5.When returning products, clearly mark the outside of the container Returned Goods Authorization (RGA) number. If you have any questions regarding the subject action or the content of the letter, contact Gabriela Anchondo at 904-279-7550.
Quantity in Commerce 2,591 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = ETN and Original Applicant = MEDTRONIC XOMED, INC.
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