Shiley 5.5PCF (UDI 20884521779737)Recalls & reported problems
Covidien LP · Pediatric Tracheostomy Tube with TaperGuard Cuff · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Shiley pediatric tracheostomy tube is a breathing tube placed through the neck into the windpipe of children. Many of the 114 reports describe the cuff leaking or deflating and the tube breaking, and 66 list the tube coming out of the windpipe unintentionally. The reports include 3 injuries and no deaths. Reports fell to 5 in the last 12 months from 17 in the previous 12 months. 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
- 114
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 20884521779737), received between Dec 16, 2021 and Feb 26, 2026 — classified as 3 injuries, 111 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (48 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
- Gas/Air Leak48
- Use of Device Problem46
- Defective Component18
- Material Split, Cut or Torn16
- Contamination /Decontamination Problem1
- Crack1
- Insufficient Device Problem Information1
- Mechanical Problem1
Patient problems
- Unintended Extubation66
- No Clinical Signs, Symptoms or Conditions42
- Insufficient Information16
- Hypoventilation3
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF WAS LEAKING DURING USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24457932 ↗MalfunctionFeb 26, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE INFLATION LINE OF THE TRACHEOSTOMY TUBE WAS BROKEN. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 24457001 ↗MalfunctionDec 1, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF DEFLATED DURING USE. THE TUBES WERE REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23687531 ↗MalfunctionDec 1, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF DEFLATED DURING USE. THE TUBES WERE REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23687507 ↗MalfunctionNov 20, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK WITH A SOUND HEARD FROM THE PATIENT'S MOUTH. THE CUFF WAS FOUND DEFLATED. IT WAS REINFLATED WITH A MANOMETER AND IMMEDIATELY DEFLATED. A NON-RETURN VALVE WAS FITTED TO THE CUFF, THEN THE CUFF DEFLATED AGAIN. THEN AN ATTEMPTED WAS MADE TO FIT A NOSTEN, THE CUFF DEFLATED AGAIN VISIBLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23612855 ↗MalfunctionOct 23, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE OF THE CUFF OF THE TRACHEOSTOMY TUBE WAS NO LONGER INFLATED APPROXIMATELY TWO WEEKS AFTER USE. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376116 ↗MalfunctionSep 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A LEAK FROM THE 15 MM CONNECTOR BASE 1 WEEK AFTER TRIAL. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23089514 ↗MalfunctionAug 5, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE DURING USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22720124 ↗MalfunctionMay 14, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT SELF-INFLATING TRACHEOSTOMY TUBES EXPERIENCED TWO INSTANCES OF FAILURE, WHILE A THIRD ONE WAS FUNCTIONING PROPERLY. THE ISSUE WAS OBSERVED DURING TESTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021261 ↗MalfunctionMay 14, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT SELF-INFLATING TRACHEOSTOMY TUBES EXPERIENCED TWO INSTANCES OF FAILURE, WHILE A THIRD ONE WAS FUNCTIONING PROPERLY. THE ISSUE WAS OBSERVED DURING TESTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22020190 ↗MalfunctionMay 12, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT WHEN THE CUFF OF THE TRACHEOSTOMY TUBE WAS TESTED LEAK WAS FOUND AS SHOWN IN THE ATTACHED VIDEO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22001961 ↗MalfunctionApr 28, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF DID NOT INFLATE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21919938 ↗MalfunctionMar 26, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE TRACH TUBE COULD NOT DEFLATE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21694810 ↗MalfunctionFeb 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A TORN CUFF WITH THE 5.5MM TRACHEOSTOMY TUBE. THE ISSUE OCCURRED AT THE PATIENT'S HOME. THE TRACH WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21445525 ↗MalfunctionFeb 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A TORN WITH THE 5.5MM PAED CUFFED DEVICE. THE ISSUE OCCURRED AT THE PATIENT'S HOME. THE TRACH WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 21445419 ↗MalfunctionFeb 18, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE TRACHEOSTOMY TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21395409 ↗MalfunctionFeb 4, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 21304645 ↗MalfunctionJan 3, 2025Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THERE WERE TWO OCCURRENCE THAT THE TRACHEOSTOMY TUBE'S CUFF LOOSE PRESSURE. THE TRACH WAS REPLACED EACH TIME IT FAILED.
Patient problems: Unintended Extubation
MAUDE report 21074773 ↗MalfunctionJan 3, 2025Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THERE WERE TWO OCCURRENCE THAT THE TRACHEOSTOMY TUBE'S CUFF LOOSE PRESSURE. THE TRACH WAS REPLACED EACH TIME IT FAILED.
Patient problems: Unintended Extubation
MAUDE report 21074772 ↗MalfunctionNov 15, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, IT WAS DISCOVERED THAT THE TRACHEOSTOMY TUBE'S CUFF "RUPTURED" AFTER 2-3 HOURS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20695779 ↗MalfunctionNov 14, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF AIR WAS NOTICED LOW AFTER 8 DAYS INTUBATED TO A PATIENT, AIR WAS ADDED BUT GRADUALLY LEAKED OUT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 20685997 ↗MalfunctionNov 8, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE TRACHEOSTOMY TUBE'S PILOT BALLOON LINE WAS FOUND TORN ABOUT 2MM CONNECTING FROM THE TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20642351 ↗MalfunctionOct 2, 2024Use of Device Problem; Defective Component; Use of Device Problem; Defective Component
ACCORDING TO THE REPORTER, DURING THE INSPECTION, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE, AND A HOLE WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350480 ↗InjurySep 30, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT MAINTAIN THE EXPECTED PRESSURE, AND THE VENTILATION OF THE PATIENT WAS IMPAIRED AND COMPROMISED. THE TUBE WAS REPLACED.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 20340421 ↗MalfunctionSep 10, 2024Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, SEVEN DAYS AFTER INTUBATION, AN ALARM WENT OFF, INDICATING A LEAK IN THE RESPIRATORY SYSTEM. THE ALARM STOPPED WHEN AIR WAS ADDED TO THE CUFF, BUT IT WENT OFF AGAIN AFTER A FEW MINUTES. A LEAK WAS SUSPECTED IN THE CUFF, SO THE TUBE WAS REPLACED, WHICH RESOLVED THE ALARM. A SCRATCH WAS NOTICED ON THE INFLATION LINE AND ASSUMED THE LEAK CAME FROM THERE.
Patient problems: Unintended Extubation
MAUDE report 20179714 ↗
Other Tube tracheostomy and tube cuff devices
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- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
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- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- 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 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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