GlideRite® Single-Use Stylet – SmallRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00879123005960), received between Nov 15, 2022 and Sep 14, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Stylet was being adjusted to assist with intubation and the stylet broke in half. This occurred prior to intubation and so stylet was not being used on the patient at the time that it broke.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752310 ↗
• InjuryFeb 10, 2026Material Separation; Positioning Problem

  A CUSTOMER REPORTED WHILE EMERGENTLY INTUBATING A TWO-MONTH-OLD PATIENT, USING A GLIDERITE SINGLE-USE STYLET - SMALL, THE STYLET BROKE IN HALF DURING THE ATTEMPTED REMOVAL FROM THE 3.5 MM ENDOTRACHIAL (ET) TUBE AFTER THE PATIENT WAS INTUBATED. THE ET TUBE WAS REMOVED AND THE PATIENT WAS RE-INTUBATED. THE INCIDENT CAUSED A FEW MINUTES DELAY IN PATIENT CARE; HOWEVER, NO HARM TO THE PATIENT WAS REPORTED. THE CUSTOMER CONFIRMED THAT NO BROKEN PIECES OF THE STYLET FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306223 ↗
• MalfunctionApr 1, 2025Material Separation; Positioning Problem; Material Separation; Positioning Problem

  A CUSTOMER REPORTED WHILE INTUBATING A PATIENT USING A GLIDERITE SINGLE-USE STYLET - SMALL, THE STYLET BROKE INSIDE A 3.5MM ENDOTRACHIAL (ET) TUBE. IT WAS REPORTED THAT THE INTUBATION WAS DIFFICULT AND THE PHYSICIAN WAS MANIPULATING THE TUBE AND ATTEMPTING TO BEND THE STYLET FOR A VERY ANTERIOR POSITION. THE STYLET WAS REMOVED FROM THE PATIENT'S AIRWAY IN TWO PIECES. IT WAS CONFIRMED THAT NO PART OF THE STYLET WAS LEFT IN THE PATIENT AND NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746692 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  A CUSTOMER REPORTED THAT DURING A PEDIATRIC PATIENT PROCEDURE, USING A GLIDERITE SINGLE-USE STYLET - SMALL, THE STYLET BROKE OFF IN THE AIRWAY AND IN THE ENDOTRACHEAL (ET) TUBE. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS TO THE CUSTOMER, NO RESPONSE HAS BEEN RECEIVED REGARDING IF THE TUBE WAS REPLACED OR IF ANY PART OF THE STYLET WAS LEFT IN THE PATIENT OR REMOVED FROM THE TUBE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457377 ↗
• MalfunctionOct 4, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  A CUSTOMER REPORTED WHILE INTUBATING A PATIENT USING A GLIDERITE SINGLE-USE STYLET - SMALL, THE STYLET SNAPPED WHILE TRYING TO REMOVE IT FROM A 3MM ENDOTRACHIAL (ET) TUBE. IT WAS REPORTED THAT A PORTION OF THE BROKEN STYLET REMAINED INSIDE THE ET TUBE BUT USERS WERE ABLE TO SUCCESSFULLY REMOVE THE BROKEN PIECE WITHOUT NEEDING TO REPLACE THE ET TUBE. IT WAS CONFIRMED THAT NO PART OF THE STYLET WAS LEFT IN THE PATIENT AND NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20375657 ↗
• MalfunctionJan 23, 2024Break; Difficult to Remove; Break; Difficult to Remove

  A CUSTOMER REPORTED VIA MEDWATCH REPORT NUMBER (B)(4) THAT A PEDIATRIC PATIENT WAS INTUBATED IN THE EMERGENCY ROOM FOR AIRWAY PROTECTION AND PRIOR TO TRANSPORT DEPARTURE TO ANOTHER FACILITY. AFTER THE ENDOTRACHEAL TUBE (ETT) WAS SECURED BY THE PHYSICIAN, THE CUFF WAS INFLATED AND THE STYLET WAS TO BE REMOVED. DURING THE STYLET REMOVAL, THE STYLET BROKE INSIDE THE ETT AND THEY WERE UNABLE TO REMOVE IT ON THE FIRST ATTEMPT. AS THE ETT WAS OCCLUDED WITH THE BROKEN STYLET, THE PATIENT WAS IMMEDIATELY BAGGED BY RESPIRATORY. THE PATIENT'S OXYGEN SATURATION (SATS) RETURNED TO 100% BEFORE THE DOCTOR MANUALLY ATTEMPTED TO REMOVE THE REST OF THE BROKEN STYLET WHICH WAS EVENTUALLY SUCCESSFULLY REMOVED. UPON BEING NOTIFIED ABOUT THE INCIDENT BY THE FACILITY, IT WAS REPORTED TO VERATHON THAT THE STYLET BROKE OFF BELOW THE STOPPER IN THE ETT UPON REMOVAL. THE PHYSICIAN USED A HEMOSTAT TO SUCCESSFULLY REMOVE THE BROKEN PIECE FROM THE ETT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18565020 ↗
• MalfunctionNov 15, 2022Break; Break

  THE FOLLOWING WAS REPORTED BY A USER FACILITY VIA MEDSUN MANDATORY AND VOLUNTARY REPORT NUMBER (B)(4) WHICH STATED THAT DURING AN EMERGENCY CARE PROCEDURE OF A 9-MONTH OLD PATIENT, USING A GLIDERITE SINGLE-USE STYLET - SMALL, THE STYLET SNAPPED PROMPTING A REPEAT INTUBATION ATTEMPT WITH A DIFFERENT TUBE AND STYLET. THE PATIENT WAS BAGGED BETWEEN INTUBATION ATTEMPTS WITH NO DIFFICULTY, WAS SUCCESSFULLY INTUBATED, AND TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU). NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: Unintended Extubation

  MAUDE report 15798141 ↗