NIM 8229307 (UDI 00763000745820)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000745820), received between Oct 31, 2023 and May 5, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PREOPERATIVE, 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 21957737 ↗
• InjuryMar 24, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT WHEN STARTING THYROID SURGERY AFTER THE NEUROLOGICAL MONITORING ENDOTRACHEAL TUBE WAS INSERTED, WHEN THE CUFF W AS BEING INFLATED, IT LEAKED AND COULD NOT BE INFLATED. 5 ML SYRINGE WAS USED AND 5 ML AIR USED TO INFLATE CUFF. AFTER ANESTHESIA INDUCTION ACCORDING TO THE PROCESS, A 7MM NEUROLOGICAL MONITORING ENDOTRACHEAL TUBE WAS INSERTED INTO THE PATIENT'S TRACHEA. WHEN PRE-PARING TO INFLATE THE CUFF TO SEAL THE AIRWAY, IT WAS FOUND THAT THE CUFF COULD NOT BE INFLATED. THIS SITUATION CAUSED THE SURGERY TO BE TEMPORARILY INTERRUPTED. IN ORDER TO MAINTAIN THE PATIENT'S OXYGEN SUPPLY, THE ANESTHESIOLOGIST USED MANUAL ASSISTED VENTILATION AND REPLACED IT WITH THE SPARE ENDOTRACHEAL TUBE AT THE SAME TIME. AFTER THE REPLACEMENT, THE PATIENT'S VENTILATION RETURNED TO NORMAL AND THE SURGERY CONTINUED. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 21674911 ↗
• MalfunctionMar 21, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE THE OPERATION INTUBATION THERE WAS NO DAMAGE NOTICED ON THE DEVICE OR ITS PACKAGING. DURING THE PRE-INFLATION, 5 ML SYRINGE WAS USED AND 5 ML AIR USED TO INFLATE CUFF. IT WAS FOUND THAT THE CUFF WAS LEAKING AND COULD NOT BE USED NORMALLY. THE PROBLEM WAS SOLVED AFTER REPLACING THE ENDOTRACHEAL TUBE WITH A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661670 ↗
• MalfunctionMar 10, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT WHEN THE TUBE WAS PRE-INFLATED BEFORE THE SURGERY , IT WAS FOUND THAT THE CUFF WAS DIFFICULT TO INFLATE AND DEFLATE, AND IT COULD NOT BE USED. THE PROBLEM WAS SOLVED AFTER REPLACING IT WITH THE NEW TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556738 ↗
• MalfunctionJan 16, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE PACKAGE WAS OPENED FOR PRE-INFLATION AND IT WAS FOUND THAT THE CUFF COULD NOT BE INFLATED AND COULD NOT BE USED. PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21165936 ↗
• MalfunctionJan 13, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT BEFORE OPERATION, THE NIM EMG TUBE PACKAGE WAS OPENED AND THE CUFF WAS PRE-INFLATED, IT WAS FOUND THAT THE CUFF WAS LEAKING AND COULD NOT BE USED NORMALLY. AND THE DEVICE WAS USED FOR THE FIRST TIME. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137713 ↗
• MalfunctionJan 2, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT PRIOR TO PROCEDURE IN NIM EMG TUBE THE AIR COULD NOT BE DEFLATED. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCT.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21052334 ↗
• MalfunctionDec 4, 2024Material Deformation; Unintended Deflation; Material Deformation; Unintended Deflation

  IT WAS REPORTED THAT PACKAGE WAS IN SEALED CONDITION PRIOR TO USE. DURING INTRA-OP, IT WAS FOUND DURING PRE-INFLATION THAT ONE SIDE OF THE ENDOTRACHEAL TUBE CUFF WAS NOT VENTILATED AND THE OTHER SIDE WAS LEAKING, MAKING IT IMPOSSIBLE TO USE NORMALLY. THERE WAS NONOTICEABLE DAMAGE ON THE CUFF AND PRODUCT PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840596 ↗
• MalfunctionMar 5, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THE THYROIDECTOMY PROCEDURE THE ENDOTRAQUEAL BALLOON DEFLATED. THERE IS NO PATIENT INJURY. ADDITIONAL INFORMATION RECIEVED AFTER FOLLOW UP THAT THE CUFF AND TUBE CHECKED PRIOR TO USE TO ENSURE PROPER FUNCTIONALITY AND IT WAS WORKING PROPERLY. THE TUBE WAS USED DURING THE PROCEDURE. LEAK WAS NOT EVIDENT WHEN TRYING TO INFLATE THE CUFF TO ESTABLISH THE AIRWAY DURING THE INTUBATION PROCESS BUT THE LEAK WAS PROGRESIVE, THE LEAK ISSUE IN THE TUBE WAS NOT DISCOVERED PRIOR TO INTUBATING THE PATIENT. THE ISSUE OCCUR AFTER THE CUFF WAS INFLATED, THE REINTUBATION WITH A NEW TUBE WAS REQUIRED.

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

  MAUDE report 18834856 ↗
• MalfunctionFeb 20, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THYROIDECTOMY, WHEN THE OPERATION PERFORMED ABOUT 10 MINUTES, THE ANESTHETIST FOUND THAT THE CUFF LEAKS AIR. SO, THE ANESTHETIST DECIDE TO CHANGE A NEW ENDOTRACHEAL TUBE. THE PROCEDURE HAS BEEN EXTENDED UPTO 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18736475 ↗
• InjuryOct 31, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING INTRA-OP, PATIENT EXPERIENCED COMPLETE BRONCHOSPASM 2MIN AFTER INTUBATION TUBE WAS REMOVED AND THEN PATIENT VENTED MANUALLY. AFTER PATIENT RECOVERED THEY TRIED A SECOND TIME AND THE PATIENT BRONCO SPASMED AGAIN 5MIN AFTER INTUBATION. THEY WERE UNABLE TO VENT WITH MACHINE OR BY HAND SO TUBE WAS REMOVED AGAIN. AFTER THE PATIENT RECOVERED THEY SWITCHED TO A TRIVANTAGE TUBE AND CASE WAS COMPLETED WITH NO ISSUE. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED STATED THAT CUFF WAS FILLED WITH AIR FROM ROOM, CUFF PRESSURE WAS NOT CHECKED OR MONITORED. PATIENT WAS REINTUBATED WITH SAME TUBE THE SECOND TIME, IT WAS INSPECTED AFTER EXTUBATING AND NO DEFECT FOUND. NO PATIENT REPOSITIONING OR TUBE REPOSITIONING OCCURRED BETWEEN ADEQUATE VENTILATION AND EMG TUBE INABILITY TO VENT. NO VISUAL INSPECTION AT TIME OF AIRWAY DIFFICULTY, TUBE WAS JUST DEFLATED AND REMOVED. BITE BLOCKED WAS USED DURING ALL INTUBATIONS.

  Patient problems: Bronchospasm; Unintended Extubation

  MAUDE report 18037456 ↗

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-