NIM® 8229306Recalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00643169789524), received between Dec 12, 2017 and Aug 18, 2025 — classified as 1 death, 37 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (86 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K925640); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 29, 2022Open, Classified

   The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

   Z-1520-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 167 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT A NEUROLOGICAL MONITORING ENDOTRACHEAL TUBE WAS PREPARED FOR PROVIDING GENERAL ANESTHESIA TO THE PATIENT. PRIOR TO ANESTHESIA, A ROUTINE CHECK OF THE CUFF'S AIRTIGHTNESS ON THE NEUROLOGICAL MONITORING ENDOTRACHEAL TUBE REVEALED THAT PART OF THE CUFF WAS ADHERED TO THE ENDOTRACHEAL TUBE WALL AND COULD NOT BE SEPARATED. IT HAD TO BE STOPPED USING AND REPLACED WITH A NEW ENDOTRACHEAL TUBE. IT WAS NOT USED ON THE PATIENT AND DID NOT CAUSE ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829700 ↗
• MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP FOR THYROID SURGERY, AFTER OPENING THE PRODUCT PACKAGE FOR FINALIZATION, IT WAS FOUND THAT THE ENDOTRACHEAL TUBE RECORDING ELECTRODE WAS ABNORMAL AND THE ELECTRODE WIRE DID NOT FIT THE TUBE BODY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307768 ↗
• MalfunctionMay 14, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED DURING PRE-OP THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS FOUND TO BE LEAKING AIR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016296 ↗
• MalfunctionMay 14, 2025Break; Unintended Deflation; Break; Unintended Deflation

  IT WAS REPORTED THAT BEFORE SURGERY THAT THE INFLATABLE CUFF HEAD OF ONE TUBE HAD FALLEN OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016048 ↗
• MalfunctionMay 5, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS FOUND TO BE LEAKING AIR BEFORE SURGERY. THE DEVICE WAS USED FOR THE FIRST TIME. THERE WAS NO DAMAGE IN THE PACKAGE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957713 ↗
• MalfunctionMar 14, 2025Break; Unintended Deflation; Break; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP, THE CUFF OF THE ENDOTRACHEAL TUBE WAS FOUND TO BE LEAKING. A 5 ML SYRINGE WAS USED TO INFLATE THE CUFF. LESS THAN 5 ML OF AIR WAS USED TO INFLATE THE CUFF AND THE PRESSURE INSIDE THE CUFF WAS NO HIGHER THAN 25CMH2O. THERE WAS NO DAMAGE IN THE PACKAGING AND IT WAS USED AFTER OPENING FROM THE SEALED PACKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604005 ↗
• MalfunctionMar 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, THERE WAS NO WAVEFORM ON NIM .THE DOCTOR TRIED TO CHECK THE ELECTRODE CHECK AND VOCALIS AND 2 WERE SHOWED V ON NIM. FINALLY ,THE DOCTOR CHANGED A ENDOTRACHEAL TUBE TO COMPLETE THE SURGERY. THERE WAS NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21602893 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, WHEN THE DOCTOR START TO DETECT NERVE, HE FOUND THERE WAS NO WAVEFORM ON NIM WHEN HE USE THE PROBE TO DETECT NERVE. THE DOCTOR TRIED TO CHECK NIM BY PATIENT SIMULATOR AND CONFIRMED THE NIM IS NORMAL. SO, THE DOCTOR THOUGHT THE PROBLEM IS ENDOTRACHEAL TUBE. FINALLY, THE DOCTOR CHANGED A NEW ENDOTRACHEAL TUBE TO COMPLETE THE SURGERY. SURGERY DELAYED BY ABOUT 5 MINUTES. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21557400 ↗
• MalfunctionMar 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER INTUBATION, NO SIGNAL COULD BE DETECTED, NOR COULD IT BE DETECTED AFTER ADJUSTING THE POSITION OF THE ENDOTRACHEAL TUBE. THE INTUBATION POSITION WAS REPEATEDLY ADJUSTED UNTIL THE VAGUS NERVE WAS EXPOSED, AND THERE WAS NO SIGNAL IN THE DETECTION. THRESHOLD SET TO 100. THERE WAS RETURN CURRENT. PATIENT¿S NERVE INTEGRITY CHECKED PRIOR TO CLOSING THE SITE AND IT WAS NORMAL. THE ¿STIMULUS DELIVERY¿ TONE HEARD WHEN ATTEMPTING TO STIMULATE THE NERVE. NO WAVEFORM DISPLAYED ON THE MONITOR WHEN ATTEMPTING TO STIMULATE THE NERVE. DRUG CISATRACURIUM WAS GIVEN BEFORE OPERATION, AND THERE WAS NO ADDITION IN THE MIDDLE. IT COULD BE DETECTED SIGNAL AFTER THE HOSPITAL CHANGING THE ENDOTRACHEAL TUBE. THERE WAS SURGICAL DELAY OF 30 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21546569 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE NEWLY UNPACKED NERVE MONITORING ENDOTRACHEAL TUBE WAS INSERTED INTO THE DESIGNATED POSITION OF THE LARYNX WHEN THE CUFF WAS INFLATED AND LEAKED AFTER INTUBATION FOR THYROID SURGERY, WHICH MADE IT UNABLE TO USE NORMALLY. THERE WAS OBVIOUS AIR LEAKAGE DURING INTUBATION INFLATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21446229 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT, PRIOR TO USE IN SURGERY, A QUALITY PROBLEM WITH THE EMG TUBE WAS FOUND. THE ENDOTRACHEAL TUBE LEAKED AIR AT THE CONNECTION BETWEEN THE TUBE BODY AND THE EXPOSED PART OF LEAD OF THE TUBE. HENCE THE DEVICE COULD NOT BE USED. THERE WAS NO LEAD WIRE THAT WAS COMING OUT OF THE TUBE SURFACE. THE PROCEDURE WAS COMPLETED WITH A SPARE ENDOTRACHEAL TUBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21446020 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRIOR TO USE, BEFORE ANESTHESIA, TESTED THE CATHETER CUFF OF THE NERVE MONITORING ENDOTRACHEAL TUBE CATHETER, AND INJECTED AIR WITH A SYRINGE. IT WAS FOUND THAT AFTER THE CUFF WAS INFLATED, THE CUFF AUTOMATICALLY SHRANK, WHICH SHOULD BE AIR LE AKAGE. IMMEDIATELY REPLACED WITH NEW ENDOTRACHEAL TUBE. PROCEDURE PERFORMED WAS SURGICAL RESECTION OF THE THYROID NODULE. THERE WAS SURGICAL DELAY OF 15 MINUTES. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445986 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE ANESTHESIA WAS STARTED, THE CUFF WAS FOUND TO BE AIR LEAKING, AND THE SPARE ENDOTRACHEAL TUBE WAS IMMEDIATELY REPLACED. THE LEAK EVIDENT WAS EVIDENT WHEN TRYING TO INFLATE THE CUFF TO ESTABLISH THE AIRWAY DURING THE INTUBATION PROCESS. THERE WAS NO PROCEDURE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21445278 ↗
• MalfunctionFeb 24, 2025Device Damaged Prior to Use; Unintended Deflation; Device Damaged Prior to Use; Unintended Deflation

  IT WAS REPORTED THAT WHILE TRYING TO INTUBATE THE ENDOTRACHEAL TUBE INTO THE PATIENT, IT WAS FOUND THAT THE CUFF LEAKED AIR. THE PACKAGING WAS DAMAGED WHILE UNBOXING THE PRODUCT, AND THE BLUE LEAD WAS ALSO FOUND DAMAGED. ANOTHER EMG TUBE HAD A LEAD DAMAGE. THERE WAS NO KNOWN PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21445110 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE HAD A AIR LEAKAGE FROM THE BALLOON. THE AIR LEAKAGE WAS NOT OBVIOUS WHEN CHECKED BEFORE, AND IT WAS FOUND WHEN ADJUSTING THE POSITION OF THE ENDOTRACHEAL TUBE. THE LEAK EVIDENT WHEN TRYING TO INFLATE THE CUFF TO ESTABLISH THE AIRWAY DURING THE INTUBATION PROCESS. THERE WAS NO DELAY IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443701 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS FOUND TO BE LEAKING BEFORE SURGERY AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443588 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THE THYROID SURGERY, THE INTUBATION FOUND THAT THE CUFF WAS AIR LEAKING AND COULD NOT BE USED NORMALLY. IN ORDER NOT TO AFFECT THE OPERATION, THEY REPLACED WITH A NEW ENDOTRACHEAL TUBE TO ENSURE THE SMOOTH OPERATION. THERE WAS A 15 MINUTES OF TIME DELAY. NO BROKEN PIECES REMAIN INSIDE THE PATIENT BODY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21443363 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT CUSTOMER WAS PERFORMING THYROID SURGERY AND ROUTINELY PERFORMED PREOPERATIVE EXAMINATIONS FOR PATIENT AND THE I NTUBATION WAS NORMAL. AFTER INTUBATION, THE CUFF WAS FOUND TO LEAK AND COULD NOT BE USED NORMALLY. THE LEAK WAS EVIDENT WHEN TRYING TO INFLATE THE CUFF TO ESTABLISH THE AIRWAY DURING THE INTUBATION PROCESS. IN ORDER TO NOT AFFECT THE SURGERY, REPLACED WITH ANOTHER CANNULA TO ENSURE THE SMOOTH PROGRESS OF THE OPERATION. THE LEAK WAS NOT DISCOVERED BY THE USER PRIOR TO INTUBATING THE PATIENT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21442947 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE OPERATION, THE ENDOTRACHEAL TUBE HAD A CUFF LEAK, AND ANOTHER TUBE HAD ITS CUFF TIP FALLEN OFF. ADDITIONALLY, THE OUTER PACKAGING OF THE PROBE WAS DAMAGED. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377158 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD AIR LEAKAGE WHICH WAS FOUND DURING PRE INFLATION AND THERE WAS CUFF LEAK. IT WAS REPLACED BY NEW TUBE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374989 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRE OP, WHEN THE ANESTHETIST TEST THE CUFF BY AIR, FOUND THAT THE CUFF LEAKED AIR. THE ANESTHETIST TRIED TO REFLATE THE CUFF BUT THE CUFF STILL LEAKED AIR. SO, THE ANESTHETIST CHANGED TO A NEW ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374821 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS INFLATED BEFORE THE SURGERY, IT WAS FOUND THAT THERE WAS AN AIR LEAK AND COULD NOT BE USED. IN ADDITION, THIS PRODUCT HAD NOT BEEN USED ON PATIENT YET, AND THERE WAS AN AIR LEAK BEFORE THE SURGERY, SO A NEW ENDOTRACHEAL TUBE WAS REPLACED IN TIME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374182 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE SURGERY WHEN THE PACKAGE WAS UNPACKED AND PRE-INFLATED, IT WAS FOUND THAT THE CUFF WAS LEAKING AIR AND COULD NOT BE USED. AFTER REPLACING IT WITH A NEW ENDOTRACHEAL TUBE, THE PROBLEM WAS SOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373014 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE USER OF HOSPITAL FOUND THERE WAS LACK OF STIMULATION PROBE AFTER UNPACKING IN ONE EMG TUBE AND BALLOON OF E NDOTRACHEAL TUBE LEAKED AIR DURING THE PREOPERATIVE ANESTHESIA INTUBATION VENTILATION TEST. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372374 ↗
• MalfunctionFeb 12, 2025Vibration; Unintended Deflation; Vibration; Unintended Deflation

  IT WAS REPORTED THAT BEFORE SURGERY, THE ANESTHETIST DISCOVERED A LEAK IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K925640. One submission often covers many models, so check the product and lot details in each record.

• Z-0901-2017 · Jun 28, 2016 · Terminated
  NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
• Z-0310-05 · Oct 29, 2004 · Terminated
  Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-