McGRATH MAC 350-013-000 (UDI 10884521816329)Recalls & reported problems
Covidien LP · Disposable Laryngoscope Blade 4 · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521816329), received between Mar 27, 2024 and Oct 14, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem3
- Material Opacification1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2024Material Opacification; Material Opacification
ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE VIDEO LARYNGOSCOPE'S BLADE WAS FOUND BLURRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20446337 ↗MalfunctionApr 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, DURING USE, THE VIDEOLARYNGOSCOPE HAD A MOISTURE WHEN USED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19028618 ↗MalfunctionApr 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, DURING USE, THE VIDEOLARYNGOSCOPE HAD A MOISTURE WHEN USED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19028317 ↗MalfunctionMar 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEO LARYNGOSCOPE BLADE HAD MOISTURE GENERATED FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986441 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.