Shiley 6.0PLCF (UDI 20884521779935)Recalls & reported problems
Covidien LP · Pediatric Tracheostomy Tube Long with TaperGuard Cuff · Class 2
Quick summary
This Shiley 6.0PLCF is a long tracheostomy tube with a TaperGuard cuff, used to keep an airway open in children. Most of the 60 reports describe cuff and pilot balloon problems: air leaking so the cuff would not inflate, the balloon or inflation line coming apart, and secretions building up inside the cuff. The most common patient issue was the tube coming out unexpectedly. There were 6 injuries and no deaths. No recalls name this device.
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
- 60
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 20884521779935), received between Aug 9, 2021 and Sep 18, 2026 — classified as 6 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (30 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 Problem30
- Gas/Air Leak24
- Material Split, Cut or Torn7
- Appropriate Device Problem Term/Code Not Available3
- Material Separation3
- Defective Component2
- Disconnection1
Patient problems
- Unintended Extubation36
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information12
- Abnormal mucus discharge2
- Discomfort2
- Hypoventilation2
- Low Oxygen Saturation1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Use of Device Problem
Patient problems: Unintended Extubation
MAUDE report 50829413 ↗MalfunctionMay 6, 2026Use of Device Problem
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD AN INFLATION AND DEFLATION ISSUE INVOLVING THE PILOT BALLOON DURING PATIENT USE IN A HOSPITAL SETTING. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106293 ↗MalfunctionApr 24, 2026Gas/Air Leak
IT WAS REPORTED THAT THE TRACH TUBE'S BALLOON LEAKED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 24983578 ↗MalfunctionApr 21, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF WAS NOT INFLATING. THE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24943704 ↗MalfunctionApr 20, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING USE, A CLOUDY SECRETION WAS OBSERVED INSIDE THE CUFF OF THE TRACHEOSTOMY TUBE, AND IT WAS TRIED TO DRAWN OR SUCTIONED WITH A SYRINGE, BUT IT COULD NOT BE DRAWN OR SUCTIONED. REPLACED WITH A TEMPORARY CANNULA.
Patient problems: Unintended Extubation
MAUDE report 24927663 ↗MalfunctionApr 20, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING USE, REQUESTED REPLACEMENT OF THE TUBE BECAUSE THERE WAS A LOT OF SECRETION INSIDE THE CUFF. WHEN THE NURSE PERFORMED THE REPLACEMENT, A SIMILAR ACCUMULATION OF SECRETIONS WAS OBSERVED INSIDE THE CUFF.
Patient problems: Unintended Extubation
MAUDE report 24927538 ↗MalfunctionApr 20, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING USE, A LOT OF SECRETION INSIDE THE CUFF WAS FOUND. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 24927513 ↗MalfunctionDec 15, 2025Disconnection; Disconnection
IT WAS REPORTED THAT DURING USE, THE CONNECTION PART OF THE TRACH TUBE'S PILOT BALLOON AND INFLATION LINE WAS FOUND DETACHED, AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23804728 ↗MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD DISLODGEMENT FROM THE ROOT OF THE INFLATION LINE DURING USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23751600 ↗InjuryOct 23, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A PEDIATRIC PATIENT WITH A TRACHEOSTOMY TUBE EXPERIENCED ISSUES WITH THE INFLATION VALVE THAT DID NOT HOLD AIR PROPERLY AND THE CUFF SPONTANEOUSLY RE-INFLATED AFTER CANNULA REMOVAL. THE PATIENT EXHIBITED PHLEGM PRODUCTION AND DISCOMFORT. IT WAS STATED THAT THE PROBLEM OCCURS IN APPROXIMATELY ONE OUT OF EVERY TWO NEW CANNULAS SUPPLIED.
Patient problems: Abnormal mucus discharge; Discomfort
MAUDE report 23372859 ↗InjuryOct 23, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A PEDIATRIC PATIENT WITH A TRACHEOSTOMY TUBE EXPERIENCED ISSUES WITH THE INFLATION VALVE THAT DID NOT HOLD AIR PROPERLY AND THE CUFF SPONTANEOUSLY RE-INFLATED AFTER CANNULA REMOVAL. THE PATIENT EXHIBITED PHLEGM PRODUCTION AND DISCOMFORT. IT WAS STATED THAT THE PROBLEM OCCURS IN APPROXIMATELY ONE OUT OF EVERY TWO NEW CANNULAS SUPPLIED.
Patient problems: Abnormal mucus discharge; Discomfort
MAUDE report 23372857 ↗MalfunctionOct 16, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT TRACHEOSTOMY TUBE HAD CUFF LEAKAGE PRIOR TO USE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310834 ↗MalfunctionJun 2, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS AS ISSUE WITH THE 6.0MM TRACHEOSTOMY CANNULA INVOLVING CUFF. THE PATIENT EXPERIENCED EMERGENCY TRACHEOSTOMY CHANGES OVER EIGHT DAYS DUE TO CUFF "RUPTURE". THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22125582 ↗MalfunctionMay 28, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS AS ISSUE WITH THE 6.0MM TRACHEOSTOMY CANNULA INVOLVING CUFF. THE PATIENT EXPERIENCED EMERGENCY TRACHEOSTOMY CHANGES OVER EIGHT DAYS DUE TO CUFF "RUPTURE". THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22095556 ↗MalfunctionMay 28, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS AS ISSUE WITH THE 6.0MM TRACHEOSTOMY CANNULA INVOLVING CUFF. THE PATIENT EXPERIENCED EMERGENCY TRACHEOSTOMY CHANGES OVER EIGHT DAYS DUE TO CUFF "RUPTURE". THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22095488 ↗MalfunctionApr 23, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A TRACHEOSTOMY CANNULA WAS INSTALLED ON A PATIENT AND HAD TO BE REPLACED DUE TO A PROBABLE QUALITY DEVIATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Unintended Extubation
MAUDE report 21890935 ↗MalfunctionMar 13, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE TRACHEAL TUBE DID NOT INFLATE DURING USE. THE TUBE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21591502 ↗MalfunctionOct 4, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE AND COLLAPSED IMMEDIATELY EVEN WHEN AIR WAS PUMPED. THE TRACH WAS REPLACED AND WHEN CHECKED UNDERWATER, AIR LEAKED.
Patient problems: Unintended Extubation
MAUDE report 20369423 ↗MalfunctionSep 24, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, LEAKING SOUND WAS HEARD AFTER EIGHT DAYS AND THE TRACH WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20296732 ↗MalfunctionSep 17, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, SIX TRACHEOSTOMY TUBE'S CUFF HAD LEAKS AND UNABLE RE-INFLATE DURING USE. THE TUBES WERE REPLACED.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 20235056 ↗MalfunctionSep 17, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, SIX TRACHEOSTOMY TUBES' CUFFS HAD BREAKAGE DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 20235049 ↗MalfunctionSep 17, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, SIX TRACHEOSTOMY TUBES' CUFFS HAD BREAKAGE DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 20235034 ↗MalfunctionSep 17, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, SIX TRACHEOSTOMY TUBES' CUFFS HAD BREAKAGE DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 20235027 ↗MalfunctionSep 17, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, SIX TRACHEOSTOMY TUBE'S CUFF HAD LEAKS AND UNABLE RE-INFLATE DURING USE. THE TUBES WERE REPLACED.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 20235020 ↗MalfunctionSep 17, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, SIX TRACHEOSTOMY TUBE'S CUFF HAD LEAKS AND UNABLE RE-INFLATE DURING USE. THE TUBES WERE REPLACED.
Patient problems: Insufficient Information; Unintended Extubation
MAUDE report 20235002 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.