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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 4 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 7 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

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

All LARYNGOSCOPE, RIGID devices →

Sources and updates

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