IntuBrite 2015.CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607411964411), received between Nov 17, 2023 and Mar 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

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.

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.

• MalfunctionMar 25, 2025Break; Break

  ALTHOUGH NO HARM OR INJURY WAS REPORTED FOR THIS INCIDENT, THE LARYNGOSCOPE BLADE SWIVELING DURING PATIENT INTUBATION COULD CAUSE A DELAY IN SECURING THE PATIENT'S AIRWAY AND WOULD POSE A RISK OF SERIOUS HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21693865 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  THE DISPOSABLE LARYNGOSCOPE BLADES THAT FLICKERED DURING PATIENT INTUBATION ARE REPORTABLE INCIDENTS. THERE WAS TWO INCIDENTS THAT OCCURRED BUT WITH TWO DIFFERENT BLADES, EACH WILL HAVE A SEPARATE REPORT. THE FIRST REPORT IS 3000219639-2025-00033.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612812 ↗
• MalfunctionJan 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE BATTERIES IN BOTH SEEM FAULTY. ON ONE THE LIGHT FLASHES QUICKLY AND THEN SHUT OFF. THE SECOND DOES NOT CONSISTENTLY TURN ON. AIRLIFE RECEIVED A SINGLE REPORT REFERENCING TWO DIFFERENT EVENTS, WHICH WERE ASSOCIATED WITH SEPERATE UNITS INVOLVING THE SAME PATIENT. THIS IS THE SECON OF THE TWO REPORTS. REFER TO 3000219639-2025-00001 FOR THE FIRST REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074718 ↗
• MalfunctionJan 3, 2025Mechanical Problem; Mechanical Problem

  THE BATTERIES IN BOTH SEEM FAULTY. ON ONE THE LIGHT FLASHES QUICKLY AND THEN SHUT OFF. THE SECOND DOES NOT CONSISTENTLY TURN ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21073913 ↗
• MalfunctionJul 17, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3000219639-2024-00063 FOR THE FIRST REPORT. IT WAS REPORTED, THE PHYSICIAN ATTEMPTED TO INTUBATE THE PATIENT; HOWEVER, THE LIGHT ON THE BLADE DID NOT WORK; THE BLADE WAS REPLACED WITH ONE THAT WORKED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT WAS ADDITIONALLY REPORTED, THE DEFECTIVE BLADE WAS TESTED AFTER THE PATIENT WAS STABLE; IT WORKED SEVERAL TIMES BUT ALSO SHORTED OUT, AS IT WOULD "COME ON AND GO BACK OFF."

  Patient problems: Insufficient Information

  MAUDE report 19767587 ↗
• MalfunctionNov 17, 2023Mechanical Problem; Mechanical Problem

  LARYNGOSCOPE HANDLES DID NOT LIGHT UP. POTENTIAL DELAY IN INTUBATION AS FIRST TWO HANDLES DID NOT LIGHT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165632 ↗