Recall Z-0696-2024— Medtronic Xomed, Inc.

Name: FDA recall Z-0696-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-07

Class II · Ongoing

Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2023-11-07. It names one FDA 510(k) clearance: K112686. Product: NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK. Reason: Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,.

Recalling firm: Medtronic Xomed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-07
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

NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK

Reason for recall

Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

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