BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0696-2024 · Initiated November 7, 2023

    Recall

    Recall Number
    Z-0696-2024
    Event Number
    93600
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    ETN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 7, 2023
    Posted
    January 10, 2024
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    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

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

    Action

    Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/07/2023 via 2-day UPS mailing. The notice explained the problem, the potential health risk, and requested segregation and quarantine pending return of the affected product. For questions, contact: [email protected].

    Distribution

    Worldwide distribution.

    Quantity

    80569 units