NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b)...
FDA Device Recall #Z-0696-2024 - Class II, November 7, 2023
Recall Summary
| Recall Number | Z-0696-2024 |
| Classification | Class II - Moderate risk |
| Date Initiated | November 7, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Xomed, Inc. |
| Location | Jacksonville, FL |
| Product Type | Devices |
| Quantity | 80569 units |
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,
Distribution Pattern
Worldwide distribution.
Lot / Code Information
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
Other Recalls from Medtronic Xomed, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2461-2025 | Class II | IPC Powerease System REF 2300000 UDI-DI: 0061... | Jul 17, 2025 |
| Z-1623-2025 | Class II | NIM Vital Nerve Monitoring System: CONSOLE NIM... | Mar 10, 2025 |
| Z-3130-2024 | Class II | Medtronic ENT Ultra Round Steel Cutting Bur, Mo... | Jul 5, 2024 |
| Z-2409-2024 | Class I | NIM Vital Nerve Monitoring systems (all serial ... | Jun 24, 2024 |
| Z-1224-2022 | Class II | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1)... | May 3, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.