Class II Recall

NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c

Summary

The FDA issued a Class II for NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822970 by Medtronic Xomed, Inc.. Reason: Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring.

Details

Source

Device Recall

External ID

Z-0696-2024

Action Date

2024-01-17

Status

Ongoing

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

Lot/Code Info: a) 8229706, GTIN 00643169782587, Serial Numbers: 0225892912, 0225894523, 0225904858, 0226227428, 0226246448, 0226246716, 0226253848, 0226258673, 0226276006, 0226294121, 0226299303, 0226299304, 0226321727, 0226350207, 0226604403, 0226628515, 0226648757, 0226684520, 0226718176, 0226745452; GTIN 00763000033941, Serial Numbers: 0225750658, 0225785080, 0225785081, 0225785083, 0225785085, 0225785587, 0225787473, 0225974682, 0225998102, 0225998104, 0226099513, 0226121951, 0226130941; b) 8229707, GTIN 00643169373099, Serial Numbers: 0225784379, 0225784380, 0225798573, 0225809609, 0225832077, 0225841439, 0225848733, 0225877835, 0225952300, 0225952301, 0225994034, 0226020502, 0226030100, 0226121428, 0226124551, 0226130051, 0226130055, 0226150740, 0226166004, 0226337996; GTIN 00643169782594, Serial Numbers: 0225798573, 0225803180, 0225805468, 0225805470, 0225824531, 0225825616, 0225828951, 0225832074, 0225832077, 0225841440, 0225846915, 0225846916, 0225848733, 0225848736, 0225848738, 0225849141, 0225869998, 0225870000, 0225877834, 0225877835, 0225886691, 0225915233, 0225915542, 0225921185, 0225929260, 0225929261, 0225932768, 0225934163, 0225952300, 0225952301, 0225956683, 0225962826, 0225972240, 0225980517, 0225983909, 0225983910, 0225994033, 0226003805, 0226004326, 0226012343, 0226012345, 0226020502, 0226020503, 0226020788, 0226030091, 0226030095, 0226030100, 0226043357, 0226057364, 0226057365, 0226057748, 0226057749, 0226079291, 0226084995, 0226086007, 0226086011, 0226086014, 0226086015, 0226097641, 0226102998, 0226112818, 0226115170, 0226124551, 0226130050, 0226130051, 0226139423, 0226149512, 0226157390, 0226157394, 0226166003, 0226166728, 0226166730, 0226177545, 0226185843, 0226186007, 0226194910, 0226203121, 0226209733, 0226232159, 0226232540, 0226246722, 0226252324, 0226276007, 0226278505, 0226279176, 0226300072, 0226300073, 0226321734, 0226321735, 0226337995, 0226337996, 0226350218, 0226352415, 0226352807, 0226352808, 0226376135, 0226385562, 0226389384, 0226389651, 0226397416, 0226398799, 0226398929, 0226406353, 0226406354, 0226406370, 0226406372, 0226441448, 0226452151, 0226455033, 0226455044, 0226512177, 0226553472, 0226591832; GTIN 00763000033958, Serial Numbers: 0225784378, 0225784379, 0225784380, 0225784381, 0225784382, 0225784383, 0225784384, 0225784385, 0225785406, 0225785407, 0225785408, 0225785410, 0225787474, 0225809609, 0225809610, 0225809612, 0225965501, 0225965502, 0225965503, 0226119539, 0226144158, 0226144159, 0226144160, 0226144161, 0226144162, 0226177144, 0226177145, 0226177687, 0226177688, 0226177689, 0226201784, 0226429408, 0226429410, 0226490525, 0226490808, 0226520885, 0226522308, 0226537201, 0226537203, 0226549613, 0226564997, 0226564998, 0226564999, 0226579984, 0226601698, 0226618838; c) 8229708, GTIN 00643169373105, Serial Numbers: 0225785422, 0225785424, 0225785467, 0225787472, 0226086712; GTIN 00763000033965, Serial Numbers: 0225785421, 0225785422, 0225785423, 0225785424, 0225785425, 0225785466, 0225785467, 0225785468, 0225787472, 0225809611, 0225975149, 0225998251, 0225998253, 0226004208, 0226004209, 0226086712, 0226121950, 0226130937, 0226130938, 0226130939; d) 8229736, GTIN 20763000041513, Serial Numbers: 0225998248; e) 8229737, GTIN 00763000041526, Serial Numbers: 0225908326, 0225908328, 0226103711; GTIN 20763000041520, Serial Numbers: 0225908183, 0225908184, 0225908185, 0225908326, 0225908327, 0225908328, 0225908329, 0225908330, 0225908332, 0225908334, 0226103711, 0226177141; f) 8229738, GTIN 20763000041537, Serial Numbers: 0225785470

Quantity Affected: 80569 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,

Distribution

Worldwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-11-07

Company

Medtronic Xomed, Inc.

Jacksonville, FL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Xomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medtronic Xomed, Inc. have FDA actions?

Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0696-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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