NIM TriVantage recallZ-0696-2024 · Medtronic Xomed, Inc. · initiated Nov 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Xomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-0696-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 7, 2023
- Posted by the FDA
- Jan 10, 2024
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 80569 units
- Product code
- ETN
- FDA submissions
- K112686
- Distribution
- Worldwide distribution.
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
Code information (models, lots, serial numbers)
Show the full code information (4k characters)
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
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM TriVantage® 8229708Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls50 reports
- NIM TriVantage® 8229737Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls31 reports
- NIM TriVantage® 8229738Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls8 reports
- NIM TriVantage® 8229736Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls2 reports
- NIM Trivantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall22 reports
Product lines
Other devices under the same FDA submission
10 devices cleared under K112686 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NIM TriVantage® 8229705Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall0 reports
- NIM TriVantage® 8229709Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall0 reports
- NIM TriVantage® 8229735Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall0 reports
- NIM TriVantage® 8229739Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall0 reports
- NIM Trivantage® 8229708Medtronic Xomed, Inc. · STIMULATOR, NERVE13 reports
- NIM Trivantage® 8229738Medtronic Xomed, Inc. · STIMULATOR, NERVE6 reports
- NIM TriVantage™ 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE4 reports
- NIM TriVantage™ 8229708Medtronic Xomed, Inc. · STIMULATOR, NERVE4 reports
- NIM Trivantage® 8229737Medtronic Xomed, Inc. · STIMULATOR, NERVE4 reports
- NIM Trivantage® 8229736Medtronic Xomed, Inc. · STIMULATOR, NERVE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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