REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5 — Class I medical device recall Z-1420-2013
Terminated recall by Medtronic Xomed, Inc., reported 2013-06-12, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in th
| Recall number | Z-1420-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2013-03-04 |
| Classified | 2013-06-04 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-01-30 |
| Distributed | 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, WA |
| Countries outside the US | AU, CA, DE, GB, IT, NO, PL |
| Quantity | 2,591 units |
| Reason classes | packaging |
| Lot numbers | 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502, 205830052, 206486732 |
| Model numbers | 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1420-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.