Shiley 85864Recalls & reported problems
Covidien LP · Intubating Stylet · Class 1
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884522004084), received between May 4, 2018 and Apr 24, 2025 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Defective Device” (12 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
- Defective Device12
- Human-Device Interface Problem10
- Defective Component2
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899759 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899718 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899699 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899688 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899663 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899640 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899595 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899506 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899464 ↗MalfunctionApr 24, 2025Defective Device; Human-Device Interface Problem; Defective Device; Human-Device Interface Problem
IT WAS REPORTED THAT DURING TESTING, A PHYSICIAN PROVIDED FEEDBACK REGARDING THE TEN STYLETS, DESCRIBING AS AN UNACCEPTABLE REPLACEMENT DUE TO BEING TOO FLIMSY, NOT HOLDING SHAPE, AND BREAKING OFF EASILY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899443 ↗MalfunctionAug 31, 2023Defective Device; Defective Device
ACCORDING TO THE REPORTER, THE STIFFNESS OF THE STYLET ON THE ENDOTRACHEAL TUBE WAS NOT HOLDING DURING PATIENT INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 17665982 ↗MalfunctionAug 30, 2023Defective Device; Defective Device
ACCORDING TO THE REPORTER, THE STIFFNESS OF THE STYLET ON THE ENDOTRACHEAL TUBE WAS NOT HOLDING DURING PATIENT INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 17649769 ↗MalfunctionApr 7, 2021Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A VERY MALLEABLE THREAD. THE ANESTHESIOLOGIST HAD TO TRY IT 3 TIMES BECAUSE IT EVEN FOLDED TOGETHER WITH A WIRE TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 11627685 ↗MalfunctionApr 5, 2021Defective Component; Defective Component
ACCORDING TO THE REPORTER, DURING USE OF THE DEVICE, THE THREAD WAS VERY MALLEABLE. ANESTHESIOLOGIST TRIED IT THREE TIMES BECAUSE IT BENT TOGETHER WITH WIRE TUBE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11614078 ↗InjuryMay 4, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE REPORTER, DURING AN EMERGENCY INTUBATION BY THE PHYSICIAN, THE LENGTH OF THE DEVICE WAS SHORT FOR INTUBATION SO HE HAD TO MODIFY IT BY BENDING OUT THE LOOP SO IT COULD BE LONG ENOUGH TO COMPLETE THE INTUBATION. IT WAS REPORTED THAT THERE WAS A DELAY IN CARE BUT NO INTUBATION WAS REQUIRED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7487749 ↗
Other STYLET, TRACHEAL TUBE devices
- Shiley 85863Covidien LP · STYLET, TRACHEAL TUBE13 reports
- GlideRite® Single-Use Stylet – SmallVerathon Medical (Canada) ULC · Stylet, Tracheal Tube7 reports
- HUDSON RCI IPN044847Teleflex Incorporated · STYLET, TRACHEAL TUBE4 reports
- HUDSON RCI IPN048992Teleflex Incorporated · STYLET, TRACHEAL TUBE4 reports
- Shiley 85865Covidien LP · STYLET, TRACHEAL TUBE3 reports
- Vital Signs™ S5000NAirlife · STYLET, TRACHEAL TUBE2 reports
- Mallinckrodt 85864Covidien LP · STYLET, TRACHEAL TUBE2 reports
- Mallinckrodt 85863Covidien LP · STYLET, TRACHEAL TUBE1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.