Shiley 8CN85ARecalls & reported problems
Covidien LP · Adult Flexible Tracheostomy Tube with TaperGuard Cuff Disposable Inner Cannula · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Covidien Shiley tracheostomy tube is used to help maintain an airway. The 71 reports mostly describe air leaks, unsecured connections, tubes splitting, and unintended extubation; 9 injuries and no deaths were reported. There is 1 open recall that began in March 2023 because undersized connectors may not secure properly to 15mm caps and circuit components. Reports increased from 1 in the previous 12 months to 21 in the latest 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
- 74
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10884521172494), received between Jul 27, 2018 and Sep 21, 2026 — classified as 9 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (32 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 24, 2023Open, Classified
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
Z-1357-2023 · Root cause: Component change control · FDA record ↗
Most reported problems
Device problems
- Gas/Air Leak32
- Use of Device Problem20
- Material Split, Cut or Torn12
- Insufficient Device Problem Information10
- Labelling, Instructions for Use or Training Problem9
- Inflation Problem5
- Deflation Problem4
- Leak/Splash4
Patient problems
- Unintended Extubation41
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information9
- Aspiration/Inhalation5
- Hypoventilation2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Pleural Effusion1
Recent adverse event reports
The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Use of Device Problem; Material Integrity Problem; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845933 ↗MalfunctionSep 18, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831471 ↗MalfunctionSep 18, 2026Use of Device Problem; Material Integrity Problem; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820199 ↗MalfunctionSep 16, 2026Use of Device Problem; Material Integrity Problem; Material Split, Cut or Torn
It was reported that prior to use, the balloon of the tracheostomy tube was completely flat and would not hold air. The balloon was described as almost ¿crunchy,¿ as if it were plastic that had been left in the sun. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50783732 ↗MalfunctionSep 16, 2026Use of Device Problem
It was reported that three tracheostomy tubes had a balloon that would not inflate and were "crunchy." There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50783463 ↗MalfunctionSep 15, 2026Use of Device Problem
It was reported that three tracheostomy tubes had a balloon that would not inflate and were "crunchy." There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773182 ↗MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50244216 ↗MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50244146 ↗MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50244135 ↗MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50244129 ↗MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50244060 ↗MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50244052 ↗MalfunctionAug 13, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50244045 ↗MalfunctionAug 12, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50227627 ↗MalfunctionAug 12, 2026Labelling, Instructions for Use or Training Problem
Patient problems: Insufficient Information
MAUDE report 50227616 ↗MalfunctionJun 17, 2026Use of Device Problem
IT WAS REPORTED THAT, BEFORE IMPLANTATION, AIR LEAKAGE OF THE CUFF OF THE TRACHEOSTOMY TUBE WAS IDENTIFIED. WHEN THE CUFF WAS INFLATED TO A PRESSURE OF 25CMH2O AND PLACED IN NORMAL SALINE, BUBBLES WERE OBSERVED, INDICATING AIR LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536988 ↗InjuryMay 15, 2026Gas/Air Leak
IT WAS REPORTED THAT AFTER 1.5 HOURS FROM PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT, THE TRACH TUBE'S CUFF WAS FOUND DEFLATED AND UNABLE TO REINFLATE. PATIENT WAS RETURNED TO SURGERY FOR TRACH EXCHANGE. TRACH WAS INSPECTED AFTER THE CASE AND CONFIRMED AN AIR LEAK.
Patient problems: Unintended Extubation
MAUDE report 25186539 ↗MalfunctionApr 24, 2026Use of Device Problem
IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD A LEAK. IT WAS ALSO MENTIONED THAT THE BALLOON HAD A SLIGHT EGG SHAPE RATHER THAN A SPHERICAL ONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983749 ↗MalfunctionApr 8, 2026
NOTED AIR LEAK IN TRACH. TRACH BALLOON TESTED BY THE SURGERY TEAM. THE BALLOON HAD A SLIGHT EGG SHAPE RATHER THAN A SPHERICAL ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24814944 ↗MalfunctionMar 13, 2026Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS ASSOCIATED WITH LEAKAGE OF THE CUFF DURING USE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24594879 ↗MalfunctionMar 13, 2026Gas/Air Leak
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS ASSOCIATED WITH LEAKAGE OF THE CUFF DURING USE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 24594862 ↗MalfunctionFeb 18, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE, A COUPLE OF TIMES, ADDITIONAL AIR WAS INFLATED INTO THE CUFF OF THE TUBE AND IT DID NOT INITIALLY SEEM LIKE AIR WAS GETTING IN. REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 24384477 ↗InjuryJan 26, 2026Defective Component; Gas/Air Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT THE ADDITIONAL AIR WAS INFLATED INTO THE CUFF OF THE TRACHEOSTOMY TUBE, AND IT DID GET IN. THERE WAS NO PATIENT INJURY.
Patient problems: Hypoventilation; No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 24185662 ↗InjuryJan 13, 2026Use of Device Problem; Obstruction of Flow
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE TRACH TUBE'S CUFF WAS NOT WORKING AND THE PATIENT COULD NOT BE PROPERLY VENTILATED, DESPITE THE PILOT BALLOON FILLING WITH AIR. THERE APPEARED TO BE A BLOCKAGE IN THE AIR TUBE BETWEEN THE PILOT LINE AND THE TRACHEOSTOMY CUFF. THE TRACHEOTOMY TUBE HAD TO BE CHANGED.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 24059302 ↗MalfunctionMar 27, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING TESTING OF THE 8.5MM TRACHEOSTOMY TUBE, A BROKEN CUFF WAS DETECTED UPON INFLATION AND DEFLATION OF THE CANNULA. THE ISSUE OCCURRED IN A HOSPITAL SETTING, AND IT WAS DECIDED TO CHANGE THE CANNULA. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708067 ↗
Other Tube tracheostomy and tube cuff devices
- Shiley 8CN85HCovidien LP · Tube tracheostomy and tube cuff1 recall2 deaths354 reports
- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.