McGRATH MAC 350-017-000 (UDI 10884521824331)Recalls & reported problems

Covidien LP · Disposable Laryngoscope Blade 2 · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521824331), received between Oct 8, 2024 and Nov 24, 2025 — classified as 5 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

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

Most reported problems

Device problems

Electrical /Electronic Property Problem3
Material Opacification1
Moisture Damage1

Patient problems

No Clinical Signs, Symptoms or Conditions4
Insufficient Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 24, 2025Material Opacification; Material Opacification
IT WAS REPORTED THAT A FOG WAS PRESENTED DURING PROCEDURE. THERE WAS CONDENSATION ON THE BLADE. DEVICE REPLACED WITH ANOTHER ONE WITH NO FOGGING ISSUES WITH THIS OTHER DEVICE. DELAY IN MANAGEMENT WAS REPORTED BUT NO CLINICAL CONSEQUENCE IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23640121 ↗
MalfunctionOct 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE PICTURE QUALITY LOOKED NORMAL PRIOR TO INTUBATION. DURING INTUBATION THE PICTURE QUALITY BECAME CLOUDED/FOGGED. ONCE THE BLADE WAS INSERTED INTO THE PATIENT'S AIRWAY THE VISUAL QUALITY BECAME POOR. TRIED ALTERNATE SIZE BLADE FROM A DIFFERENT LOT NUMBER AND DID NOT EXPERIENCED THE SAME ISSUE. TRIED SEVERAL SIZE 2 BLADES FROM THE SAME LOT NUMBER AND EXPERIENCE THE SAME ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398111 ↗
MalfunctionOct 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE "FOG" ON THE BLADE PREVENTED THE CHILD FROM BEING INTUBATED. ANOTHER BLADE WAS USED TO INTUBATE THE PATIENT AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397862 ↗
MalfunctionOct 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ACCORDING TO THE REPORTER, THE PICTURE QUALITY LOOKED NORMAL PRIOR TO INTUBATION. DURING INTUBATION THE PICTURE QUALITY BECAME "CLOUDED/FOGGED." ONCE THE BLADE WAS INSERTED INTO THE PATIENT'S AIRWAY THE VISUAL QUALITY BECAME POOR. AN ALTERNATE SIZE BLADE FROM A DIFFERENT LOT NUMBER WAS USED AND DID NOT EXPERIENCE THE SAME ISSUE. SEVERAL SIZE 2 BLADES FROM THE SAME LOT NUMBER WERE TRIED AND EXPERIENCED THE SAME ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397784 ↗
MalfunctionOct 8, 2024Moisture Damage; Moisture Damage
ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS FOG SEEN ON THE SIZE 2 BLADE OF THE DEVICE. IT WAS THEN USED WITH DIFFICULTY ON A 3 YEAR OLD CHILD, WHICH ON EXPOSURE, THE APPEARANCE OF THE MIST MADE IT IMPOSSIBLE TO VISUALIZE THE GLOTTIS AND DID BLIND INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 20397617 ↗

Device details

UDI-DI	`10884521824331`
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
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McGRATH MAC 300-000-000
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McGRATH 340-000-000
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McGRATH MAC 301-000-000
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2 recalls90 reports
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Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
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n/a 8404AXC
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
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McGRATH 340-000-000
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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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