NIM CONTACT® 8229506Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169789555), received between Feb 16, 2022 and Mar 13, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, TUBE DID NOT WORK AS INTENDED. APPLIED BEFORE START OF CASE (AS USUAL), WHEN PROBE PLACED ON NERVE NIM TUBE DID NOT REGISTER. NO INTERVENTION PERFORMED. THE REPORTED EVENT RESULT IN A PROCEDURE DELAY 5-10 MINUTES DURING SET-UP. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). NO PATIENT INJURY REPORTED. THERE WAS NO ANY VISUAL AND/OR AUDIBLE INDICATORS THAT ALERTED THE USER OF THE ISSUE. THE ISSUE DID NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528858 ↗
• MalfunctionSep 9, 2022Failure to Sense; Failure to Sense

  ON FOLLOW-UP IT WAS REPORTED THAT STIMULUS ADJUSTED FIRST TO 0.8 AND THEN TO 1.0. THRESHOLD SET TO 100. NO BASELINE WAS PERFORMED. THE PATIENT'S NERVE INTEGRITY CHECKED BEFORE CLOSING THE SITE WITH COMPETITOR'S STIMULATOR. THERE WAS NO VISUAL AND/OR AUDIBLE INDICATORS TO ALERT THE USER TO THE PROBLEM AND THERE WAS NO ERROR CODE DISPLAYED. NO WAVEFORM DISPLAYED. A SHORT-ACTING RELAXANT WAS USED AND AFTER 30 MINUTES THE ANESTHESIOLOGIST PERFORMED THE TESTS WITH THE EQUIPMENT INTENDED FOR THIS PURPOSE AND IT WAS FOUND THAT THE MUSCLE RELAXANT WAS NO LONGER PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394397 ↗
• MalfunctionJul 19, 2022Use of Device Problem; Use of Device Problem

  THE HCP REPORTED THAT TUBE WAS INSERTED INTO THE TRACHEA PAST THE VOCAL CORDS AND WHEN THE NIM TUBE WAS STIMULATED IT DID NOT WORK. THERE WERE NO ADVERSE PATIENT ISSUES. THE ANESTHESIA PERSONAL WERE ABLE TO REINTUBATED USING A NIM 7.0 TUBE INSTEAD. THE SURGERY COMPLETED WITH ANESTHESIA REINTUBATED USING A NIM 7.0 TUBE INSTEAD.

  Patient problems: Unintended Extubation

  MAUDE report 15054515 ↗
• MalfunctionFeb 16, 2022Gas/Air Leak; Gas/Air Leak

  HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTUBATION PROCESS CUFF WAS NOT HOLDING AIR, HAD TO EXTUBATE THE TUBE AND BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 10 MIN, NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540055 ↗