Recall Z-1420-2013— Medtronic Xomed, Inc.

Name: FDA recall Z-1420-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-04

Class I · Terminated

Class I FDA medical device recall by Medtronic Xomed, Inc., initiated 2013-03-04, terminated 2014-01-30. It names one FDA 510(k) clearance: K112686. 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: 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..

Recalling firm: Medtronic Xomed, Inc.
Classification: Class I
Status: Terminated
Initiated: 2013-03-04
Terminated: 2014-01-30
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K112686 — NEXT GEN EMG ENDOTRACHEAL TUBEMedtronic Xomed, Inc.·cleared 2012-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.