Shiley 5.5PCF (UDI 10884521103566)Recalls & reported problems
Covidien LP · Pediatric Tracheostomy Tube with TaperGuar Cuff · Class 2
Quick summary
This Shiley pediatric tracheostomy tube helps children breathe through an opening in the neck. The 42 reports mostly describe cuff problems such as air leaks, trouble inflating or deflating, and damaged inflation lines, often leading to tube replacement, with 5 injuries mentioned and no deaths. No recalls name this device. There were 0 reports in the last 12 months, compared with 6 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884521103566), received between Dec 8, 2020 and Mar 3, 2025 — classified as 5 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (20 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
- Use of Device Problem20
- Gas/Air Leak17
- Material Split, Cut or Torn5
- Defective Component3
- Insufficient Device Problem Information2
- Fluid/Blood Leak1
- Labelling, Instructions for Use or Training Problem1
- Material Discolored1
Patient problems
- Unintended Extubation32
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information3
- Hypoventilation2
- Hemorrhage/Blood Loss/Bleeding1
- Low Oxygen Saturation1
- Pneumonia1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS AIR LEAKAGE WITH THE TRACHEOSTOMY TUBE, BUT IT WAS UNKNOWN WHERE IT STARTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21511378 ↗MalfunctionMar 3, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF COULD NOT BE INFLATED DURING USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21511364 ↗MalfunctionFeb 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT ON THE 21ST DAY OF NORMAL USE, THERE WAS A FREQUENT OCCURRENCE OF RESPIRATORY ALARM DUE TO LEAK. UPON CHECKING, IT WAS TOLD THAT THERE WAS DAMAGE TO THE TRACHEOSTOMY'S CUFF. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21398765 ↗MalfunctionFeb 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING EXTUBATION, AIR COULD NOT BE WITHDRAWN FROM THE CUFF OF A 5.5MM TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21352118 ↗MalfunctionFeb 5, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING USE, A TRACHEOSTOMY TUBE WOULD NOT DEFLATE, LEADING TO A REQUEST FOR THE RETURN AND REPLACEMENT OF THE DEFECTIVE DEVICE. THE ISSUE WAS OBSERVED INTRA-OPERATIVELY, AND THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR HARMS AS A RESULT OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21315797 ↗MalfunctionFeb 4, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE 5.5MM TRACHEOSTOMY TUBE'S CUFF DEFLATED AFTER A FEW DAYS. THE TRACH WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21309530 ↗MalfunctionSep 18, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S INFLATION LINE WAS FOUND DAMAGED. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20245551 ↗MalfunctionSep 15, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD SIZING ISSUE WHICH CAUSED THE TUBE'S PROXIMAL PART TO LEAK. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20220961 ↗MalfunctionJul 25, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING PATIENT USE, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK THAT CAUSED THE VENTILATOR ALARM. NO IMPROVEMENT WAS OBSERVED EVEN AFTER AIR WAS INJECTED, AND WHEN REPLACED IT WITH AN ADJUSTABLE FIT, THE ALARM STOPPED. IT WAS OBSERVED THAT THE CUFF DID NOT INFLATE EVEN WHEN THE PRODUCT WAS INFLATED WITH AIR. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19829532 ↗MalfunctionApr 23, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, WHEN THE CUFF OF THE TRACHEOSTOMY TUBE WAS CHECKED, IT WAS IN A STATE WHERE AIR COULD BE DRAWN OVER AND OVER AGAIN DUE TO CUFF BREAKAGE. THE TUBE HAS BEEN REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19164793 ↗InjuryApr 23, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE PATIENT'S SPO2 WAS 98%, BUT VENTILATION DOES NOT RISE ABOVE 30-40. WHEN THE CUFF OF THE TRACHEOSTOMY TUBE WAS CHECKED, IT WAS IN A STATE WHERE AIR COULD BE DRAWN OVER AND OVER AGAIN. THE TUBE HAS BEEN REPLACED.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 19164688 ↗MalfunctionApr 4, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE AIR IN THE TRACHEOSTOMY TUBE'S CUFF WAS DEFLATED WITH A SYRINGE, BUT THE PILOT BALLOON DID NOT INDENT, SO IT WAS UNCLEAR WHETHER IT WAS DEFLATED DURING ROUTINE REPLACEMENT. FOR SAFETY, THE INFLATION LINE WAS CUT AND THE TRACHEOSTOMY TUBE WAS REMOVED. THE TRACH WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19044562 ↗MalfunctionMar 1, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING USED ON THE PATIENT, A CUFF PRESSURE CHECK WAS PERFORMED, AND THE SPEED OF AIR IN THE CUFF OF THE TRACHEOSTOMY TUBE DECREASED FASTER. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18822981 ↗MalfunctionFeb 28, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF PRESSURE BEGAN TO DECREASE AFTER A SHORT TIME DURING THE PROCEDURE. THE PROXIMAL SIDE OF THE PILOT BALLOON WAS ALSO DEFORMED, AND THERE WAS LEAK. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 18800408 ↗MalfunctionFeb 19, 2024Material Discolored; Material Discolored
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CONNECTOR REGION WAS FOUND TO BE CLOUDY DURING REPLACEMENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18736057 ↗MalfunctionJan 29, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD DAMAGE NEAR THE CONNECTION PART BETWEEN THE CANNULA AND THE PILOT LINE AND AIR DID NOT ENTER THE CUFF FOR ABOUT THREE WEEKS DURING USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 18602649 ↗MalfunctionJan 14, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INFLATION LINE WAS DAMAGED, DISCONNECTED FROM THE TUBE. THE ISSUE HAPPENED IN PATIENT'S HOME AFTER 21ST DAY OF USE. TUBE WAS REPLACED WITH A NEW PRODUCT AT THE HOSPITAL.
Patient problems: Unintended Extubation
MAUDE report 18509706 ↗MalfunctionJan 12, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, ON THE 21ST DAY, WHEN AIR WAS INSERTED, THE AIR IN THE CUFF CAME OUT AND DID NOT INFLATE. THE TUBE WAS REPLACED WITH THE SAME PRODUCT.
Patient problems: Unintended Extubation
MAUDE report 18506564 ↗MalfunctionJan 10, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE INFLATION LINE OF THE TRACHEOSTOMY TUBE WAS DAMAGED. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 18488186 ↗MalfunctionJan 5, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, WHEN THE CUFF PRESSURE OF THE TRACHEOSTOMY TUBE WAS CHECKED, THE PRESSURE DID NOT INCREASE, SO WHEN THE PROXIMAL SITE OF THE PILOT BALLOON TUBE WAS CHECKED, IT WAS FOUND TO BE BROKEN, AS SHOWN IN THE ATTACHED PHOTO. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 18460885 ↗MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE REPORTER, THERE WERE WATER DROPS INSIDE THE INFLATION LINE OF THE TRACHEOSTOMY TUBE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 18452111 ↗MalfunctionJan 2, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK DURING PATIENT USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 18429882 ↗MalfunctionDec 15, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S FLANGE, WHERE THE NECK STRAP PASSES, WAS DAMAGED. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 18340701 ↗MalfunctionDec 6, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD LEAK DURING USED, AND WAS REPLACED BY THE HOME CARE NURSE.
Patient problems: Unintended Extubation
MAUDE report 18279052 ↗MalfunctionDec 6, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT LINE LEAKED DURING USE. BECAUSE OF THE EMERGENCY, THE PATIENT'S FAMILY MEMBER GLUED THE LEAKAGE POINT IN PLACE. THE DOCTOR REPLACED THE TUBE AT THE HOSPITAL.
Patient problems: Unintended Extubation
MAUDE report 18275586 ↗
Other Tube tracheostomy and tube cuff devices
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- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.