McGRATH MAC 350-017-000 (UDI 10884521816336)Recalls & reported problems

Covidien LP · Disposable Laryngoscope Blade 2 · Class 1

All models of McGRATH MAC (11)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521816336), received between May 17, 2023 and Dec 8, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Aug 10, 2023Class IIOpen, Classified
Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
Z-0168-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Electrical /Electronic Property Problem3

Patient problems

Hemorrhage/Blood Loss/Bleeding2
Unspecified Tissue Injury2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 8, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE VIDEO LARYNGOSCOPE'S BLADES HAD FOG DURING THE INTUBATION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18293460 ↗
InjuryMay 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THERE WAS FOGGING USING THE VIDEOLARYNGOSCOPE WITH THE REPORTED BLADE #2. THE PATIENT SUFFERED BLEEDING FROM NOSE DUE TO TRAUMA OR MULTIPLE INTUBATION ATTEMPTS. THERE WERE NO FURTHER COMPLICATIONS THAN THE BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 16962110 ↗
InjuryMay 17, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THERE WAS FOGGING IN THE VIDEOLARYNGOSCOPE USING THE REPORTED BLADE WHICH WAS CAUSED BY THE PATIENT'S BREATH. VIDEO WAS OBSCURED CAUSING TRAUMA AND BLEEDING FROM THE MULTIPLE ATTEMPTS TO INTUBATE THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 16946806 ↗

Device details

UDI-DI	`10884521816336`
Brand	McGRATH MAC
Model	350-017-000
Company	Covidien LP
Product code	CCW · LARYNGOSCOPE, RIGID
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 29, 2026

Device type (GMDN): Laryngoscope blade, single-use

The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Other LARYNGOSCOPE, RIGID devices

McGRATH MAC 301-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 recalls202 reports
McGRATH MAC 300-000-000
Covidien LP · LARYNGOSCOPE, RIGID
1 recall1 death205 reports
n.a. 8404HX
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
242 reports
McGRATH 340-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 deaths192 reports
McGRATH MAC 301-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 recalls90 reports
n.a. 8404BXC
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
141 reports
n/a 8404AXC
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
108 reports
McGRATH 340-000-000
Covidien LP · LARYNGOSCOPE, RIGID
84 reports

All LARYNGOSCOPE, RIGID devices →

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 13, 2026 · each recall links to the FDA recall notice
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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