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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

FDA Recall Z-0696-2024 · Posted 2024-01-10

Recalling FirmMedtronic Xomed, Inc.
Recall StatusOpen, Classified
Product CodeETN
Date Initiated2023-11-07
Product Quantity80569 units

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,

Firm 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].

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112686NEXT GEN EMG ENDOTRACHEAL TUBEMedtronic Xomed, Inc. · 2012-06-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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