PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 17, 2024 Initiated: November 7, 2023 #Z-0696-2024

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,

Details

Recalling Firm
Medtronic Xomed, Inc.
Units Affected
80569 units
Distribution
Worldwide distribution.
Location
Jacksonville, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Medtronic Xomed, Inc.. Units affected: 80569 units.
Why was this product recalled?
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
Which agency issued this recall?
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0696-2024.