The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected specific lot numbers of NIM Trivantage EMG Endotracheal Tube imported and distributed by Medtronic Philippines, Inc.
| Product Name | Customer Facing Number | Lot / Serial Number |
| EMG Tube 8229705 NIM Trivantage 5.0MM ID | 8229705 | 0218663943, 0218762694, 0219904500, 0220293429, 0220584798, 0220756285, 0220774358, 0221736070, 0221805033, 0222186741, 0222495993, 0222591367, 0222832233 |
| EMG Tube 8229706 NIM Trivantage 6.0MM ID | 8229706 | 0218663944, 0218664146, 0218762695, 0218762697, 0218762698, 0218762699, 0219010138, 0219010139, 0219010140, 0219010141, 0219010142, 0219272545, 0219278186, 0219278187, 0219278188, 0219278189, 0219278190, 0219444156, 0219444157, 0219444158, 0219444159, 0219444160, 0219444161, 0219836614, 0219836616, 0219969085, 0219972526, 0219972527, 0219972528, 0220087596, 0220087597, 0220087598, 0220293430, 0220293431, 0220293432, 0220293433, 0220293434, 0220293435, 0220371534, 0220371535, 0220371536, 0220371537, 0220517618, 0220517619, 0220584803, 0220584804, 0220734720, 0220769468, 0220769469, 0220769470, 0220878556, 0220878557, 0220934885, 0221123594, 0221123639, 0221248867, 0221248868, 0221248869, 0221493241, 0221543452, 0221543453, 0221637121, 0221637122, 0221710524, 0221805030, 0221805031, 0221805039, 0221805041, 0222024594, 0222048142, 0222057391, 0222140123, 0222200982, 0222200983, 0222200984, 0222239874, 0222239875, 0222352848, 0222396630, 0222428754, 0222465659, 0222495994, 0222495995, 0222495996, 0222542347, 0222542348, 0222563000, 0222563288, 0222684388, 0222719941, 0222738659 |
| EMG Tube 8229707 NIM Trivantage 7.0MM ID | 8229707 | 0218664148, 0218664149, 0218664150, 0218664151, 0218664152, 0218664153, 0218664154, 0218664155, 0218664156, 0218664157, 0218664158, 0218762700, 0218762701, 0218762702, 0218762703,
0218762704, 0218762705, 0218762806, 0218762807, 0218762809, 0218762811, 0218762812, 0218762814, 0218762815, 0219010143, 0219010144, 0219010145, 0219010806, 0219010807, 0219010808, 0219010809, 0219010810, 0219010811, 0219010812, 0219010813, 0219010814, 0219010815, 0219010816, 0219010817, 0219010818, 0219010819, 0219010820, 0219010821, 0219010822, 0219278191, 0219278192, 0219278193, 0219278194, 0219278195, 0219278196, 0219278197, 0219278198, 0219444369, 0219444370, 0219444371, 0219444372, 0219444373, 0219444374, 0219444375, 0219444376, 0219723502, 0219952958, 0219952959, 0219985176, 0219985177, 0220008823, 0220008824, 0220008825, 0220010546, 0220010547, 0220010548, 0220033883, 0220033885, 0220037915, 0220047459, 0220047460, 0220057008, 0220057009, 0220057010, 0220057011, 0220076607, 0220081032, 0220081037, 0220087591, 0220087599, 0220087600, 0220087601, 0220087602, 0220087603, 0220087886, 0220142052, 0220142053, 0220142054, 0220142055, 0220142057, 0220142058, 0220142059, 0220142060, 0220142062, 0220142063, 0220142064, 0220142065, 0220149776, 0220149778, 0220149779, 0220230467, 0220230468, 0220230469, 0220230472, 0220370784, 0220370785, 0220371526, 0220371527, 0220371528, 0220371529, 0220371530, 0220371531, 0220371532, 0220371533, 0220517189, 0220517190, 0220517191, 0220517192, 0220517193, 0220517194, 0220517195, 0220517196, 0220517197, 0220517198, 0220517199, 0220517200, 0220517201, 0220517202, 0220517620, 0220517621, 0220622252, 0220622253, 0220637407, 0220637408, 0220637409, 0220637410, 0220688264, 0220688265, 0220691509, 0220691510, 0220734718, 0220756281, 0220756282, 0220756283, 0220756284, 0220769471, 0220769472, 0220798476, 0220804919, 0220813969, 0220813970, 0220817686, 0220817687, 0220826216, 0220826217, 0220845825, 0220846126, 0220857889, 0220878558, 0220878559, 0220878560, 0220878561, 0220878562, 0220878563, 0220913062, 0220935486, 0220935487, 0220935488, 0220935489, 0220974382, 0221040035, 0221040036, 0221056071, 0221056072, 0221069155, 0221073627, 0221082044, 0221082126, 0221090327, 0221090328, 0221097604, 0221097605, 0221098066, 0221098067, 0221118571, 0221118572, 0221123591, 0221123638, 0221146333, 0221146457, 0221146458, 0221146459, 0221146460, 0221146461, 0221146462, 0221146463, 0221146879, 0221146889, 0221146901, 0221248875, 0221248876, 0221248877, 0221248878, 0221248879, 0221248880, 0221248881, 0221248882, 0221248883, 0221248884, 0221248885, 0221378722, 0221378724, 0221378725, 0221379386, 0221379387, 0221379388, 0221493665, 0221493866, 0221514981, 0221526915, 0221526917, 0221526918, 0221526919, 0221526920, 0221571421, 0221599117, 0221599118, 0221599119, 0221599181, 0221637118, 0221651974, 0221656118, 0221656119, 0221659143, 0221659144, 0221736003, 0221736005, 0221736786, 0221766208, 0221766209, 0221766211, 0221772984, 0221805043, 0221805044, 0221886337, 0221893433, 0221893434, 0221893435, 0221897719, 0221897720, 0221924396, 0221931540, 0221938901, 0221938902, 0221962166, 0221967955, 0222024589, 0222057392, 0222069692, 0222069693, 0222069694, 0222093329, 0222093330, 0222101075, 0222106107, 0222110921, 0222110922, 0222136940, 0222139599, 0222139600, 0222140118, 0222140119, 0222140120, 0222140125, 0222140446, 0222163047, 0222168488, 0222168489, 0222168491, 0222168492, 0222168493, 0222202226, 0222202227, 0222202228, 0222202229, 0222202230, 0222202231, 0222202232, 0222239878, 0222239881, 0222239882, 0222239883, 0222239884, 0222239885, 0222240046, 0222240047, 0222312293, 0222312878, 0222334220, 0222334221, 0222334222, 0222334223, 0222334224, 0222358414, 0222358415, 0222358416, 0222358417, 0222358418, 0222396631, 0222396632, 0222396633, 0222396634, 0222396635, 0222456848, 0222456849, 0222456850, 0222456851, 0222456852, 0222476127, 0222476128, 0222476129, 0222476130, 0222476131, 0222495997, 0222495998, 0222495999, 0222496000, 0222496001, 0222496002, 0222496003, 0222542349, 0222542350, 0222542351, 0222542352, 0222542353, 0222563001, 0222563002, 0222563003, 0222563004, 0222563005, 0222563286, 0222563287, 0222684391, 0222684392, 0222684393, 0222684394, 0222684395, 0222719938, 0222719943, 0222719944, 0222719945, 0222720028, 0222720029, 0222738660, 0222738661, 0222738662, 0222738663, 0222738664, 0222738665, 0222857891, 0222857892, 0222857893, 0222857894, 0222857895, 0222857896, 0222857897, 0222857898, 0222857900 |
| EMG Tube 8229708 NIM Trivantage 8.0MM ID | 8229708 | 0218664159, 0218664160, 0218664161, 0218664162, 0218664163, 0218762816, 0218762818, 0218762819, 0218762820, 0218762821, 0218762822, 0219278199, 0219278200, 0219278201, 0219278202,
0219444162, 0219444163, 0219444164, 0219444165, 0220087592, 0220087593, 0220087594, 0220087595, 0220142106, 0220142108, 0220142109, 0220142110, 0220142111, 0220228325, 0220293438, 0220293439, 0220293440, 0220370781, 0220370782, 0220370783, 0220517614, 0220517615, 0220517616, 0220517617, 0220658898, 0220730554, 0220855164, 0220855447, 0220855448, 0220855449, 0220873204, 0220935503, 0220935505, 0220935648, 0220935651, 0220935654, 0221056080, 0221056081, 0221097602, 0221097603, 0221146343, 0221146446, 0221146448, 0221146936, 0221146951, 0221248874, 0221378720, 0221588082, 0221588083, 0221637123, 0221710525, 0221710926, 0221851580, 0221851581, 0221893436, 0221931647, 0221931648, 0222031317, 0222081991, 0222101073, 0222140121, 0222140122, 0222217071, 0222240048, 0222302776, 0222358419, 0222358421, 0222396636, 0222396637, 0222456853, 0222456854, 0222476133, 0222542354, 0222563290, 0222720030, 0222739006 |
| EMG Tube 8229709 NIM Trivantage 9.0MM ID | 8229709 | 0218275305, 0218275886, 0218452814, 0218452815, 0218496850, 0218515807, 0218540733, 0218540734, 0218540735, 0219906760, 0220586086, 0220973095, 0221248873, 0221517237, 0221805028, 0222187092, 0222248291, 0222336506 |
| EMG Tube 8229735 3PK NIM Trivantage 5MM | 8229735 | 0218275302, 0218452816, 0220584797, 0220883592, 0221996821, 0222146974 |
| EMG Tube 8229736 3PK NIM Trivantage 6MM | 8229736 | 0218762829, 0218762830, 0219010516, 0219010517, 0219010518, 0219904499, 0219985174, 0220293436, 0220293437, 0220584799, 0220880266, 0220998690, 0221038763, 0221246105, 0221248866,
0221378719, 0221543451, 0221805267, 0222024592, 0222140124, 0222240053, 0222527962, 0222684399 |
| EMG Tube 8229737 3PK NIM Trivantage 7MM | 8229737 | 0010791039, 0218762831, 0218762832, 0218762833, 0218762834, 0218762835,
0219010519, 0219733959, 0219744709, 0219785665, 0219788607, 0219788608, 0219795296, 0219795301, 0219795302, 0219795303, 0219802958, 0219802959, 0219802960, 0219836612, 0219836613, 0219904496, 0219904497, 0219972534, 0219972535, 0219972536, 0219972537, 0219972538, 0219985178, 0220010550, 0220010551, 0220010552, 0220010554, 0220010555, 0220087604, 0220087605, 0220142112, 0220142113, 0220142114, 0220142116, 0220228945, 0220230426, 0220230427, 0220230428, 0220230429, 0220230430, 0220230480, 0220230481, 0220293442, 0220293443, 0220293444, 0220713083, 0220734719, 0220734721, 0220769474, 0220769475, 0220769476, 0220785122, 0220790899, 0220826214, 0220826215, 0220847263, 0220857890, 0220998691, 0221010990, 0221034442, 0221035008, 0221038764, 0221056079, 0221248870, 0221248871, 0221248872, 0221378718, 0221463272, 0221463273, 0221493238, 0221493240, 0221493867, 0221493869, 0221543449, 0221637119, 0221637120, 0221718467, 0221766210, 0221805034, 0221805035, 0221805037, 0221805038, 0221910040, 0221924395, 0221931646, 0221967715, 0222024590, 0222024595, 0222024596, 0222034109, 0222034111, 0222065770, 0222119577, 0222123196, 0222187098, 0222334225, 0222358420, 0222396638, 0222456855, 0222496004, 0222496005, 0222542355, 0222562999, 0222563291, 0222684396, 0222719939, 0222720026, 0222739007, 0222739008, 0222908102 |
| EMG Tube 8229738 3PK NIM Trivantage 8MM | 8229738 | 0218762837, 0218762838, 0218762840, 0218762841, 0218762842, 0219011550,
0219011551, 0219011552, 0219861136, 0219861141, 0219878782, 0219878783, 0219878784, 0219879026, 0219952951, 0219952952, 0220142117, 0220142118, 0220142119, 0220142120, 0220142121, 0220855453, 0220966544, 0221038762, 0221146339, 0221247365, 0221463276, 0221514982, 0221543448, 0221765700, 0221898348, 0222007804, 0222031318, 0222187101, 0222476134, 0222542356, 0222684398, 0222739009 |
| EMG Tube 8229739 3PK NIM Trivantage 9MM | 8229739 | 0218762824, 0220584805, 0222024591, 0222272928, 0222476135 |
Medtronic has received complaint reports from customers experiencing issues with the use of the abovementioned medical device. Reported issues include users experiencing difficulty passing the electrode check on the NIM Mainframe immediately after intubating the patient, losing the connection between the EMG Tube and the Mainframe during a procedure, resulting in an “Electrode Off”, “Lead Off”, or “ Channel Not Reading” error message on the NIM console screen and inability to proceed with nerve monitoring. Lastly, receiving excess signal noise from the NIM console due to lead-off issues.
Through investigation, the root cause of the non-conforming product was determined to be in the adhesive application step of the manufacturing process. This issue impacts specific productions lots manufactured between 28 August 2019 and 25 October 2021. Corrective actions have been implemented to address the underlying issue and new products will not be impacted by this issue.
In light of the foregoing, all concerned healthcare professional, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lot numbers of NIM Trivantage EMG Endotracheal Tube.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.