McGRATH MAC 350-005-000 (UDI 10884521824317)Recalls & reported problems
Covidien LP · Disposable Laryngoscope Blade 3 · Class 1
All models of McGRATH MAC (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521824317), received between Mar 11, 2024 and Apr 20, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem9
- Material Opacification7
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Material Opacification
IT WAS REPORTED THAT A VIDEOLARYNGOSCOPE BLADE HAD A BLURRED LENS PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927790 ↗MalfunctionJun 30, 2025Material Opacification; Material Opacification
IT WAS REPORTED THAT THE BLADE FOGS UP VERY OFTEN EVEN WHEN A NEW ONE WAS USED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22365416 ↗MalfunctionJun 11, 2025Material Opacification; Material Opacification
IT WAS REPORTED THAT THE SCREEN OF THE VIDEOLARYNGOSCOPE FOGGED UP OR WAS NOT CLEAR INTRA-OPERATIVELY. THE HANDLE¿S SCREEN AND BLADE TIP WERE WIPED SEVERAL TIMES, BUT THERE WAS NO CHANGE. AS A RESULT, THE BLADE WAS REPLACED, AND THE PROBLEM WAS SOLVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22181684 ↗MalfunctionFeb 7, 2025Material Opacification; Material Opacification
IT WAS REPORTED THAT DURING USE, THE VIDEO LARYNGOSCOPE'S SCREEN WAS FOGGY USING THE REPORTED BLADE. THE ANTI-FOG COATING WAS NOT APPLIED PROPERLY, SO IT WAS HARD TO SEE THE SCREEN. THE LENS ITSELF WAS FINE. THE BLADE WAS REPLACED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334858 ↗MalfunctionNov 20, 2024Material Opacification; Fitting Problem; Material Opacification; Fitting Problem
ACCORDING TO THE REPORTER, THE BLADE CLAW PART WAS TWISTED, SO IT COULD NOT BE CONNECTED TO THE HANDLE WITH A CLICK. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND ANOTHER FAULT WAS FOUND REGARDING THE ANTI-FOG ON THE BLADE PRISM FAILING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737886 ↗MalfunctionNov 1, 2024Electrical /Electronic Property Problem; Material Opacification; Electrical /Electronic Property Problem; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USE, A BLACK DOT APPEARED IN THE CORNER OF THE SCREEN OF THE VIDEOLARYNGOSCOPE. IT DID NOT APPEARED USING BLADE AND THE ISSUE WAS FIXED AFTER REPLACING THE BLADE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20588241 ↗MalfunctionOct 11, 2024Material Opacification; Material Opacification
ACCORDING TO THE REPORTER. DURING THE PROCEDURE, THE VIDEO LARYNGOSCOPE'S SCREEN BECAME CLOUDY AND INTUBATION COULD NOT BE PERFORMED. WHEN THE INTUBATION WAS PERFORMED WITH ANOTHER BLADE, THERE WERE NO PROBLEMS, IT WAS DETERMINED THAT THE BLADE WAS DEFECTIVE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427973 ↗MalfunctionAug 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, PRIOR TO USAGE, FOUR VIDEO LARYNGOSCOPE BLADES WERE FOUND BLURRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19906892 ↗MalfunctionAug 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, PRIOR TO USAGE, FOUR VIDEO LARYNGOSCOPE BLADES WERE FOUND BLURRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19906865 ↗MalfunctionAug 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, PRIOR TO USAGE, FOUR VIDEO LARYNGOSCOPE BLADES WERE FOUND BLURRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19906775 ↗MalfunctionAug 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, PRIOR TO USAGE, FOUR VIDEO LARYNGOSCOPE BLADES WERE FOUND BLURRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19906761 ↗MalfunctionMar 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE BLADE ANTI-FOG WAS NOT GOOD ENOUGH AS IT CAUSED FOGGING BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882471 ↗MalfunctionMar 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE BLADE ANTI-FOG WAS NOT GOOD ENOUGH AS IT CAUSED FOGGING BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882455 ↗MalfunctionMar 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE BLADE ANTI-FOG WAS NOT GOOD ENOUGH AS IT CAUSED FOGGING BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882442 ↗MalfunctionMar 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE BLADE ANTI-FOG WAS NOT GOOD ENOUGH AS IT CAUSED FOGGING BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882436 ↗
Other LARYNGOSCOPE, RIGID devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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