McGRATH MAC 350-013-000 (UDI 10884521824324)Recalls & reported problems
Covidien LP · Disposable Laryngoscope Blade 4 · Class 1
All models of McGRATH MAC (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521824324), received between Jul 5, 2023 and Apr 20, 2026 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Material Opacification” (15 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
- Material Opacification15
- Electrical /Electronic Property Problem3
- Fitting Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Choking1
- Foreign Body In Patient1
- Insufficient Information1
- Unspecified Tissue Injury1
Recent adverse event reports
The 20 most recent of 20 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 24927828 ↗MalfunctionJan 29, 2026Material Opacification
IT WAS REPORTED THAT MOISTURE GENERATION WAS OBSERVED WITH THE VIDEOLARYNGOSCOPE BLADE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215143 ↗MalfunctionJan 29, 2026Material Opacification
IT WAS REPORTED THAT MOISTURE GENERATION WAS OBSERVED WITH THE VIDEOLARYNGOSCOPE BLADE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215139 ↗MalfunctionJan 29, 2026Material Opacification
IT WAS REPORTED THAT MOISTURE GENERATION WAS OBSERVED WITH THE VIDEOLARYNGOSCOPE BLADE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PAT IENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215084 ↗MalfunctionJan 29, 2026Material Opacification
IT WAS REPORTED THAT MOISTURE GENERATION WAS OBSERVED WITH THE VIDEOLARYNGOSCOPE BLADE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PAT ENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215052 ↗MalfunctionJan 29, 2026Material Opacification
IT WAS REPORTED THAT MOISTURE GENERATION WAS OBSERVED WITH THE VIDEOLARYNGOSCOPE BLADE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215043 ↗MalfunctionJan 29, 2026Material Opacification
IT WAS REPORTED THAT MOISTURE GENERATION WAS OBSERVED WITH THE VIDEOLARYNGOSCOPE BLADE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215032 ↗MalfunctionJan 29, 2026Material Opacification
IT WAS REPORTED THAT MOISTURE GENERATION WAS OBSERVED WITH THE VIDEOLARYNGOSCOPE BLADE PRIOR TO USE, AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215022 ↗MalfunctionAug 18, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING USE, BOTH ENDOTRACHEAL TUBE'S PILOT LINE WERE CUT AND CUFF DID NOT DEFLATE. THE TUBE WAS REMOVED WITH THE CUFF NOT DEFLATED THAT CAUSED TRAUMA TO THE PATIENTS LARYNX. A FIBROSCOPY WAS PERFORMED TO REMOVE CLOTS WHICH ALSO CAUSED DIFFICULTY IN VENTILATION, DECALCIFICATION NECESSARY.
Patient problems: Insufficient Information
MAUDE report 22827089 ↗MalfunctionJan 6, 2025Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USAGE, IT WAS FOUND THAT BOTH VIDEO LARYNGOSCOPE'S BLADES WERE FOGGY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078960 ↗MalfunctionJan 6, 2025Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USAGE, IT WAS FOUND THAT BOTH VIDEO LARYNGOSCOPE'S BLADES WERE FOGGY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078922 ↗MalfunctionOct 29, 2024Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USE, THE FOUR VIDEO LARYNGOSCOPE'S BLADE WERE FOGGY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20560124 ↗MalfunctionOct 29, 2024Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USE, THE FOUR VIDEO LARYNGOSCOPE'S BLADE WERE FOGGY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20560037 ↗MalfunctionOct 29, 2024Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USE, THE FOUR VIDEO LARYNGOSCOPE'S BLADE WERE FOGGY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20560004 ↗MalfunctionOct 29, 2024Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USE, THE FOUR VIDEO LARYNGOSCOPE'S BLADE WERE FOGGY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559986 ↗MalfunctionSep 19, 2024Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, DURING PRE-INSPECTION, THE VIDEO LARYNGOSCOPE'S BLADE TIP PART WAS MAKING SCREEN DISPLAY BLURRY. THERE WA S NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20259715 ↗MalfunctionMar 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE'S BLADE ANTI-FOG WAS NOT GOOD ENOUGH AS IT WAS FOGGY BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18963708 ↗MalfunctionMar 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE'S BLADE ANTI-FOG WAS NOT GOOD ENOUGH AS IT WAS FOGGY BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18963696 ↗MalfunctionJan 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE'S BLADE WAS FOGGY BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18500128 ↗InjuryJul 5, 2023Fitting Problem; Fitting Problem
ACCORDING TO THE REPORTER, THE VIDEO LARYNGOSCOPE'S PLASTIC BLADE WAS MISSING SHORTLY AFTER AN EMERGENCY INTUBATION. THE NEXT MORNING, THE PATIENT WAS SUCCESSFULLY EXTUBATED AND WAS NOTED TO BE GAGGING A LITTLE. AN OBJECT WAS SEEN IN THE BACK OF THE PATIENT'S MOUTH AND WAS REMOVED AND IT TURNS OUT TO BE THE MISSING PLASTIC BLADE. THERE WAS A REPORTED UNSPECIFIED HARM.
Patient problems: Choking; Foreign Body In Patient; Unspecified Tissue Injury
MAUDE report 17261497 ↗
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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