FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: 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 number
- Z-0696-2024
- Recalling firm
- Medtronic Xomed, Inc.
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2023-11-07
- Posted
- 2024-01-10
- Terminated
- not on file
- Reason
- Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- Root cause
- Under Investigation by 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: neuro-quality@medtronic.com.
- Quantity
- 80569 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K112686"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28