NIM® 8229307 (UDI 00643169789531)Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 00643169789531), received between Jun 16, 2017 and Sep 4, 2025 — classified as 45 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (59 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 138 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Failure to Unfold or Unwrap; Unintended Deflation; Failure to Unfold or Unwrap; Unintended Deflation

  IT WAS REPORTED THAT DURING THYROID SURGERY, UNEVEN CUFF INFLATION OF THE EMG TUBE WAS OBSERVED DURING INTUBATION. ALTHOUGH THE CUFF AND TUBE WERE CHECKED PRIOR TO USE AND CONFIRMED TO BE FUNCTIONING PROPERLY, A CUFF ISSUE WAS IDENTIFIED AFTER THE EMG TUBE INTUBATED INTO THE PATIENT, AND LEADING TO IMMEDIATE EXTUBATION. THE 5 ML OF AIR WAS USED TO INFLATE THE CUFF AND 5ML SIZE SYRINGE WAS USED TO INFLATE THE ENDOTRACHEAL TUBE CUFF . THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE BACKUP PRODUCT, RESULTING IN A DELAY OF UP TO 10 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 22960629 ↗
• MalfunctionAug 11, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE OPERATION, THE ENDOTRACHEAL TUBE PACKAGE WAS UNPACKED AND THE CUFF COULD NOT BE INFLATED DURING THE PRE-INFLATION OPERATION. EMG TUBE WAS NOT USED FOR THE FIRST TIME. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770269 ↗
• MalfunctionJul 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROID CANCER SURGERY, THE ENDOTRACHEAL TUBE WAS ALREADY CONNECTED, BUT THERE WAS NO SIGNAL FROM THE MONITOR, AND THERE WAS NO RESPONSE WHEN THE ENDOTRACHEAL TUBE WAS ADJUSTED. THE SIGNAL COULD ONLY BE OBTAINED BY REPLACING THE ENDOTRACHEAL TUBE. USED SHORT-ACTING MUSCLE RELAXANT AT 1 TIME ED95 FOR 40 MINUTES BEFORE STARTING MONITORING. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 22507929 ↗
• MalfunctionJun 23, 2025Material Protrusion/Extrusion; Unintended Deflation; Material Protrusion/Extrusion; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP, THE EMG TUBE CANNOT BE USED. AFTER UNPACKING THE PACKAGE, THE CUSTOMER FOUND THAT THE WIRE ELECTRODE ON THE EMG TUBE WALL FELL OFF AND THE ELECTRODE PUNCTURED THE CUFF, MAKING THE ENDOTRACHEAL TUBE UNUSABLE. THEREFORE, THE EMG TUBE COULD NOT BE USED DURING SURGERY, AND A NEW ENDOTRACHEAL TUBE WAS REPLACED IMMEDIATELY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309353 ↗
• InjuryMay 9, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT , DURING A THYROID SURGERY THE CUFF AND TUBE WAS CHECKED PRIOR TO USE AND FUNCTIONED NORMALLY. 5 ML SYRINGE WAS USED TO INFLATE 4 ML AIR. CUFF WAS FOUND TO BE LEAKING AFTER INTUBATION, TRIED TO INFLATE THE CUFF TO CREATE AN AIRWAY, IT LEAKED AIR. ANESTHESIA MACHINE DETECTED ABNORMALITIES AND COULD NOT MONITOR NORMALLY. IN ORDER NOT TO AFFECT THE SURGERY, REPLACED THE ENDOTRACHEAL TUBE TO ENSURE THE SMOOTH PROGRESS OF THE SURGERY. THERE WAS NO INJURY TO THE PATIENT.

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

  MAUDE report 21991929 ↗
• MalfunctionApr 1, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE SURGERY, IT WAS DISCOVERED THAT THE CUFF OF AN ENDOTRACHEAL TUBE WAS LEAKING. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736459 ↗
• MalfunctionMar 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP THE CUFF WAS BLOCKED AND IT WOULD NOT CHANGE REGARDLESS OF WHETHER THE AIR WAS PUMPED OUT OR INFLATED. 5ML OF SYRINGE WAS USED TO INFLATE 5 ML OF AIR. THE OPERATION WAS COMPLETED BY REPLACING IT WITH THE SPARE TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21674707 ↗
• MalfunctionMar 19, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE EMG TUBE WAS USED DURING THE OPERATION. THE BALLOON OF THE MONITORING ENDOTRACHEAL TUBE WAS FOUND TO HAVE AIR LEAKAGE. THE DOCTOR REPLACED THE ENDOTRACHEAL TUBE IN TIME. 15-20 ML AIR WAS USED TO INFLATE THE CUFF. NO INTRACUFF PRESSURE WAS MONITORED. SYRINGE, REGULAR AIR WAS USED TO INFLATE THE CUFF. NO PATIENT INJURY.

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

  MAUDE report 21641683 ↗
• MalfunctionMar 14, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER INTUBATING THE EMG TUBE, THE DEVICE PASSED THE SELF-TEST. WHEN THE CRICOTHYROID MUSCLE WAS LIGHTLY TAPPED, THERE WAS NO EMG DISPLAY. ADDITIONALLY, WHEN THE VAGUS NERVE WAS STIMULATED, THERE WAS NO EMG VALUE BEATING. THE ENDOTRACHEAL TUBE WAS REPLACED WITH A SPARE PRODUCT, AND IT RETURNED TO NORMAL. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21603508 ↗
• MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP DURING THE SURGERY, IN THE PROCESS OF MONITORING THE NERVE SIGNAL, THERE WAS NO SIGNAL AT ALL FROM THE ENDOTRACHEAL TUBE. THERE WAS STILL NO MYOELECTRIC SIGNAL AFTER MULTIPLE ADJUSTMENTS. THE CURRENT STIM RETURN WAS NOT SHOWING 0 AND THERE WAS NO WAVEFORM DISPLAYED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602287 ↗
• MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTUBATION WAS PERFORMED, WITHOUT THE USE OF MUSCLE RELAXANT AND/OR LIDOCAINE. AFTER CONNECTING TO THE PATIENT INTERFACE AND CHECKING THE ELECTRODES, THE ELECTRODES WERE NOT RECOGNIZED BY THE MONITOR, IT MUST BE THE RETURN ELECTRODE. A NEW ATTEMPT WAS MADE TO POSITION THE TUBE, THROUGH DIRECT VISUALIZATION (VIDEOLAGINGOSCOPE), AND IT STILL DID NOT RECOGNIZE IT. WHEN CHECKING THE ELECTRODES, IT CONTINUED WITH A RED "X", EVEN AFTER TRYING TO REPOSITION IT. NO STIMULATION WAS PERFORMED, AS THE TUBE HAD TO BE CHANGED. THERE WAS VISUAL INDICATOR. AFTER SEVERAL ATTEMPTS, IT WAS DECIDED TO PERFORM A NEW INTUBATION. NO PATIENT INJURY.

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

  MAUDE report 21594267 ↗
• MalfunctionMar 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRIOR TO USE, WHILE UNPACKING IT WAS FOUND THAT 1 ENDOTRACHEAL TUBE BALLOON WAS LEAKED, AND 1 ENDOTRACHEAL TUBE WAS DISCONNECTED FROM THE TUBE WALL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591043 ↗
• MalfunctionMar 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE, THE EMG TUBE WAS INSERTED AND PASSED ELECTRODE CHECKS BUT DID NOT WORK. THEY ADJUSTED THE TUBE TO SEE IF THEY COULD GET A RESPONSE FROM THE PATIENT AND STILL NOTHING. THEY REPLACED THE TUBE AND THE NEW TUBE WORKED PERFECTLY. THEY INSPECTED THE FIRST TUBE FOR DAMAGE BUT COULD NOT FIND ANYTHING TO EXPLAIN WHY IT DID NOT WORK. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21545138 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP, UPON INITIAL INSPECTION OF THE TUBE, THE CUFF DID NOT APPEAR TO HOLD AIR. THERE WAS NO PATIENT INVOLVED. ANOTHER TUBE WAS USED TO COMPLETE THE CASE AND THAT FUNCTIONED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446991 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT AFTER INSERTING ENDOTRACHEAL TUBE, HEALTH CARE PROFESSIONAL INFLATED IT NORMALLY AND FOUND THAT THE CUFF LEAKED AND FAILED TO INFLATE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446129 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THYROIDECTOMY, THE ENDOTRACHEAL TUBE WAS USED. IT WAS FOUND THAT THE ENDOTRACHEAL TUBE WAS LEAKING THE AIR AND COULD NOT BE USED NORMALLY. THE LEAK WAS EVIDENT WHEN TRYING TO INFLATE THE CUFF TO ESTABLISH THE AIRWAY DURING THE INTUBATION PROCESS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444099 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Unintended Deflation; Incorrect, Inadequate or Imprecise Result or Readings; Unintended Deflation

  IT WAS REPORTED THAT NO EMG SIGNAL WAS DETECTED DURING THE OPERATION, THERE IS NO IMPROPER OPERATION, AND THERE WAS NO MUSCLE RELAXATION THROUGHOUT THE OPERATION. AFTER THE ENDOTRACHEAL TUBE WAS PULLED OUT, CUFF LEAKAGE WAS FOUND. THERE WAS NO WAVE FORM DISPLAYED ON THE MONITOR WHEN ATTEMPTING TO STIMULATE THE NERVE. POSTOPERATIVE LARYNGOSCOPY FOUND THAT THE VOCAL CORD MOVEMENT WAS NORMAL AND THE RECURRENT LARYNGEAL NERVE WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED WITHOUT USING THE DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443913 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT WHILE ESTABLISHING THE AIRWAY DURING INTUBATION PROCESS WHERE BITE BLOCK WAS ALSO USED, THE ANESTHESIOLOGIST FOUND THAT THE AIR BAG WAS LEAKING, AND THE AIR BAG COULD NOT BE OPENED. AFTER SEVERAL TESTS, IT REFLECTS THE AIR BAG LEAK, AND THE REPLACEMENT PRODUCT WAS REPLACED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21443329 ↗
• MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT WHILE ESTABLISHING THE AIRWAY DURING INTUBATION PROCESS WHERE BITE BLOCK WAS ALSO USED, THE ANESTHESIOLOGIST FOUND THAT THE AIR BAG WAS LEAKING, AND THE AIR BAG COULD NOT BE OPENED. AFTER SEVERAL TESTS, IT REFLECTS THE AIR BAG LEAK, AND THE REPLACEMENT PRODUCT WAS REPLACED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21443305 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE OPERATION, THE EMG TUBE CUFF HAD AN AIR LEAKAGE. THE CUFF AND TUBE WERE CHECKED FOR PROPER FUNCTIONALITY PRIOR TO USE, AND DURING THIS INSPECTION, A SIGNIFICANT AIR LEAK WAS DISCOVERED. THIS LEAK WAS IMMEDIATELY IDENTIFIED BY THE USER BEFORE INTUBATING THE PATIENT. ALSO THE PROBE FOUND TO BE DAMAGED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375221 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE COULD NOT BE INFLATED BEFORE INTUBATING THE PATIENT AND COULD NOT BE INSERTED INTO THE PATIENT. DEVICE REPLACED WITH A NEW ENDOTRACHEAL TUBE. THE PROCEDURE WAS EXTENDED FOR 10 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371873 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE SURGERY, THE ENDOTRACHEAL TUBE WAS INFLATED BUT IT LEAKED AIR AND COULD NOT BE USED. SURGERY WAS EXTENDED BY 15 MINUTES. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371773 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE SURGERY, THE ENDOTRACHEAL TUBE HAS AN AIR LEAK AND THE PROBE TIP WAS FOUND TO BE FLAT WHICH WAS SUPPOSED TO BE SPHERICAL. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371601 ↗
• MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING PRE-INFLATION, THE STANDARD ENDOTRACHEAL TUBE WAS LEAKING AIR. 3ML OF AIR WAS USED TO INFLATE THE CUFF. IT WAS REPLACED WITH THE NEW ENDOTRACHEAL TUBE AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371455 ↗
• MalfunctionFeb 12, 2025Vibration; Unintended Deflation; Vibration; Unintended Deflation

  IT WAS REPORTED THAT DURING PRE-OP, THE ENDOTRACHEAL TUBE BALLOON LEAKED AIR, AND THE SURGERY WAS COMPLETED WITH BACKUP ENDOTRACHEAL TUBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367836 ↗

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-