NIM CONTACT® 8229507Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169789562), received between Apr 13, 2018 and Aug 18, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 29, 2022Class IOpen, 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-1519-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT WHILE NIM ENDOTRACHEAL TUBE PLACED WITH VIDEOSCOPE, VENTILATED WELL FOR SEVERAL MINUTES THEN HIGH PEAK PRESSURES/NO VENTILATION, ASSESSMENT AND TREATMENT OF PATIENT, VENTILATION ONLY IMPROVED WHEN TUBE REPLACED WITH STANDARD ENDOTRACHEAL TUBE. SEE ATTACHED USER FACILITY MEDWATCH MW5119519.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 17574530 ↗
• InjuryJul 14, 2023Increase in Pressure

  USING MEDTRONIC NIMS ENDOTRACHEAL TUBE PLACED WITH VIDEOSCOPE, VENTILATED WELL FOR SEVERAL MINUTES THEN HIGH PEAK PRESSURES/NO VENTILATION, ASSESSMENT AND TREATMENT OF PATIENT, VENTILATION ONLY IMPROVED WHEN TUBE REPLACED WITH STANDARD ENDOTRACHEAL TUBE.

  Patient problems: Insufficient Information

  MAUDE report 17337130 ↗
• InjuryDec 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PROCEDURE ONCE THE PATIENT WAS INTUBATED, THE ANESTHESIOLOGIST NOTICED THAT THE TUBE WAS LEAKING, CHECKED AND VERIFIED THAT IT WAS BROKEN. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO INJURY TO PATIENT. ON FOLLOW-UP IT WAS REPORTED THAT THE SLEEVE AND TUBING CHECKED PRIOR TO USE TO ENSURE PROPER OPERATION AND IT WORKED. THE ANESTHESIOLOGIST NOTICED THE ISSUE AFTER INTUBATION AND AIRWAY WAS ESTABLISHED. THE PATIENT WAS NO RE-POSITIONED. CUFF PRESSURE NOT QUANTITATIVELY MONITORED. THERE WAS ONLY USUAL DIFFICULTY OF THE CONTACT TUBE. AIR WAS USED TO INFLATE THE CUFF. BITE BLOCK NOT USED TO SECURE THE TUBE. EXTUBATE THE PATIENT AND USED A NEW TUBE.

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

  MAUDE report 15983912 ↗
• MalfunctionAug 22, 2022Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT COULD NOT MAKE THE DEVICE TO WORK. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15268275 ↗
• MalfunctionAug 22, 2022Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT COULD NOT MAKE THE DEVICE TO WORK. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15268248 ↗
• MalfunctionApr 13, 2018Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED THAT INTEROPERATIVE, THERE WAS AN INFLATION/DEFLATION ISSUE WITH THE ENDODTRACHEAL TUBE CUFF. PATIENT REINTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 7430332 ↗