NIM 8229306 (UDI 00763000745813)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00763000745813), received between Jan 12, 2024 and Jul 20, 2025 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (20 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE OPERATION BEGAN, WHEN THE TUBE WAS PRE-INFLATED, IT WAS FOUND THAT THE CUFF COULD NOT BE INFLATED. THE CUFF WAS SUSPECTED TO BE LEAKING AND COULD NOT BE USED. THE PROBLEM WAS SOLVED AFTER REPLACING THE NEW TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552246 ↗
• MalfunctionMay 30, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRIOR TO USE, BEFORE TRACHEAL INTUBATION, THE SURGEON OPENED THE PACKAGING, AND FOUND A HOLE IN THE CUFF, MAKING IT UNUSABLE. THE EVENT WAS NOT ASSOCIATED WITH THE EVENT. THE NEW ENDOTRACHEAL TUBE WAS REPLACED AND THE OPERATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120186 ↗
• MalfunctionMay 14, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS LEAKING AIR BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017342 ↗
• MalfunctionMay 14, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRIOR TO USE THERE WAS NO NOTICEABLE DAMAGE ON THE PRODUCT OR ITS PACKAGE. A 5 ML(CC) SYRINGE USED. NO MORE THAN 5ML OF AIR WAS USED TO INFLATE. EMG TUBE CUFF WAS LEAKING AIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016128 ↗
• MalfunctionMay 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP, EMG TUBE CUFF WAS LEAKING DURING THE INFLATION TEST BEFORE INTUBATION. THE CUFF WAS INFLATED WITH NO MORE THAN 5ML OF AIR WITH 5 ML(CC) SYRINGEB AND NO MORE THAN 25CMH2O PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007960 ↗
• MalfunctionMay 12, 2025Break; Unintended Deflation; Break; Unintended Deflation

  IT WAS REPORTED THAT BEFORE SURGERY, THE INFLATABLE BALLOON OF AN ENDOTRACHEAL TUBE WAS LEAKING WHEN USED FOR THE FIRST TIME. THE PACKAGE HAD NO DAMAGES AND WAS IN SEALED CONDITION WHEN OPENED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000650 ↗
• MalfunctionMay 9, 2025Break; Unintended Deflation; Break; Unintended Deflation

  IT WAS REPORTED THAT BEFORE SURGERY, THE INFLATABLE CUFF TIP OF AN ENDOTRACHEAL TUBE HAD FALLEN OFF. THERE WAS NO PACKAGING DAMAGE OBSERVED DURING THE INSPECTION OF THE SAMPLE AND AS SOON AS OPENED THE PACKAGE, IT WAS FOUND THAT THE INFLATION CUFF HAD FALLEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992007 ↗
• MalfunctionMay 9, 2025Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRE-OP THERE WAS NO NOTICEABLE DAMAGE ON THE PRODUCT PACKAGE. THE CUFF OF THE ENDOTRACHEAL TUBE WAS ADHERED TO THE TUBE WALL. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991537 ↗
• MalfunctionMay 9, 2025Unintended Deflation; Unintended Deflation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991363 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT BEFORE THE SURGERY, THE CUFF TIP OF AN ENDOTRACHEAL TUBE WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991276 ↗
• MalfunctionMay 7, 2025Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRE-OP THERE WAS NO NOTICEABLE DAMAGE ON THE PRODUCT PACKAGE. THE CUFF OF THE ENDOTRACHEAL TUBE WAS ADHERED TO THE TUBE WALL. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974782 ↗
• MalfunctionMay 6, 2025Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRE-OP, THE CUFF OF THE ENDOTRACHEAL TUBE WAS ADHERED TO THE TUBE WALL. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965323 ↗
• MalfunctionMay 5, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED DURING PRE-INFLATED OF THE TUBE BEFORE THE SURGERY, IT WAS FOUND THAT THE CUFF COULD NOT BE INFLATED. THE 5ML OF AIR WAS USED TO INFLATED THE CUFF, IT WAS SUSPECTED TO BE LEAKING AND COULD NOT BE USED. THE PROBLEM WAS SOLVED AFTER REPLACING IT WITH A NEW TUBE.  THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958310 ↗
• MalfunctionMay 5, 2025Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT BEFORE SURGERY THAT THE INFLATABLE CUFF OF AN ENDOTRACHEAL TUBE HAD DETACHED FROM THE TUBE WALL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958018 ↗
• MalfunctionApr 29, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRIOR TO PROCEDURE IT WAS FOUND THAT THE CUFF OF THE LOWER CANNULA WAS LEAKING. CUFF WAS INFLATED WITH 5ML OF AIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924424 ↗
• MalfunctionApr 28, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP, THE CUFF OF THE LOWER INTUBATION TUBE WAS LEAKING. THERE WERE NO NOTICEABLE DAMAGE ON THE EMG TUBE WHEN OPENED. THERE WERE NO NOTICEABLE DAMAGE ON THE EMG TUBE PACKAGE. 5ML SYRINGE WAS USED TO INFLATE THE ENDOTRACHEAL TUBE CUFF. AIR WAS USED TO INFLATE THE CUFF. DEVICE WAS USED FOR THE FIRST TIME. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916300 ↗
• MalfunctionApr 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP, IT WAS FOUND THAT THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED AIR. A 5 ML SYRINGE WAS USED TO INFLATE THE ENDOTRACHEAL TUBE CUFF AND NO MORE THAN 5ML OF AIR WAS USED TO INFLATE THE CUFF. THERE WAS NO DAMAGE NOTICED IN THE TUBE AND PACKAGING AFTER OPENING FROM THE SEALED PACKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21897024 ↗
• MalfunctionApr 22, 2025Material Protrusion/Extrusion; Unintended Deflation; Material Protrusion/Extrusion; Unintended Deflation

  IT WAS REPORTED THAT THERE WAS NO NOTICEABLE DAMAGE ON EMG TUBE OR ITS PACKAGING. BEFORE SURGERY ENDOTRACHEAL TUBE ¿S CUFF LEAKED AIR. A 5 ML (CC) SYRINGE WAS USED AND NO MORE THAN 5ML AIR WAS USED TO INFLATE THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879828 ↗
• MalfunctionApr 22, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE SURGERY, A ENDOTRACHEAL TUBE¿S CUFF WAS ADHERED TO THE TUBE WALL. THERE WERE NO HOLE, BENT AND LEAKAGE IN THE TUBE. THE DEVICE WAS USED FOR THE FIRST TIME. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878839 ↗
• MalfunctionApr 1, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE OPERATION, IT WAS FOUND THAT THE CUFF OF AN ENDOTRACHEAL TUBE WAS LEAKING. 5ML OF SYRINGE WAS USED AND LESS THAN 5 ML AIR WAS INFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735990 ↗
• MalfunctionMar 18, 2025Product Quality Problem; Unintended Deflation; Product Quality Problem; Unintended Deflation

  IT WAS REPORTED THAT AFTER OPENED THE ENDOTRACHEAL TUBE PACKAGE BEFORE THE SURGERY, FOUND THAT THE ENDOTRACHEAL TUBE CUFF WAS DIFFICULT TO OPEN. AFTER RUBBING AND INFLATING THE CUFF WITH 5 ML SYRINGE AND 5 ML OF AIR, THE CUFF SURFACE WAS UNEVEN, SO GAVE UP USING THE ENDOTRACHEAL TUBE. THE PROCEDURE WAS EXTENDED BY 10 MINUTES. THE PROCEDURE WAS COMPLETED BY ANOTHER EMG TUBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628264 ↗
• MalfunctionFeb 6, 2025Failure to Unfold or Unwrap; Unintended Deflation; Failure to Unfold or Unwrap; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE OPERATION, AFTER UNPACKING IT WAS FOUND THAT THE CUFF OF A 6MM ENDOTRACHEAL TUBE WAS ADHERED TO THE TUBE WALL. THE EVENT WAS NOT ASSOCIATED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323628 ↗
• InjuryFeb 4, 2025Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT AFTER THE SURGICAL INTUBATION, IT WAS FOUND THAT THE ENDOTRACHEAL TUBE WAS NOT VENTILATING SMOOTHLY. AFTER TESTING WITH A SUCTION TUBE, IT WAS FOUND THAT IT WAS NOT VENTILATING AND COULD NOT BE USED. AFTER REPLACING THE NEW ENDOTRACHEAL TUBE, THE PROBLEM WAS SOLVED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21300955 ↗
• InjuryNov 11, 2024Use of Device Problem; Unintended Deflation; Use of Device Problem; Unintended Deflation

  IT WAS REPORTED THAT AFTER INTUBATION, IT WAS FOUND THAT THE CUFF WAS LEAKING, AND THE ANESTHESIA MACHINE WAS MONITORING ABNORMALLY AND COULD NOT MONITOR NORMALLY. THERE WAS NO KNOWN PATIENT INJURY RELATED TO THE EVENT.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649631 ↗
• MalfunctionJul 9, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PREOPERATIVE, ONE ENDOTRACHEAL TUBE HAD NO RETURN ELECTRODE AND ONE ENDOTRACHEAL TUBE BALLOON LEAKED AIR. THERE WAS NO PATIENT INJURY RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19698935 ↗

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-