Shiley 110880Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 40884521068231), received between Feb 7, 2019 and Aug 8, 2024 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K082520); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, IT WAS OBSERVED THAT WATER CAME OUT FROM THE ENDOTRACHEAL TUBE'S PILOT BALLOON. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19943786 ↗
• MalfunctionFeb 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THERE WERE WATER DROPLETS ACCUMULATING IN THE PILOT BALLOON AND INFLATION LINE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18744069 ↗
• MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THERE WERE WATER DROPLETS ACCUMULATING INSIDE THE CUFF, THE PILOT BALLOON, AND THE INFLATION LINE OF THE ENDOTRACHEAL TUBE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18614070 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THERE WERE WATER DROPLETS ACCUMULATING INSIDE THE CUFF, THE PILOT BALLOON, AND THE INFLATION LINE OF THE ENDOTRACHEAL TUBE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18610831 ↗
• MalfunctionJan 11, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS WATER DROPLETS ACCUMULATED IN THE TRACHEOSTOMY TUBE'S CUFF DURING PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18499887 ↗
• MalfunctionJul 20, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 15067204 ↗
• MalfunctionFeb 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, WHEN THE AIR WAS REMOVED FROM THE CUFF OF THE DEVICE AT THE TIME OF EXTUBATION, A LARGE AMOUNT OF MOISTURE WAS DETECTED IN THE SYRINGE. THE PATIENT HAD A SUCCESSFUL REPLACEMENT OF THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418049 ↗
• MalfunctionDec 30, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER INTUBATION, THE PATIENT FELT SOMETHING STRANGE WHEN THE CUFFS WERE INFLATED, AFTERWARDS, AN AIR LEAK OCCURRED IN THE CUFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117932 ↗
• MalfunctionJun 18, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF EXPANSION CANNOT BE PERFORMED WITHOUT APPLYING EQUIVALENT PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024613 ↗
• MalfunctionMar 3, 2021Labelling, Instructions for Use or Training Problem; Use of Device Problem; Labelling, Instructions for Use or Training Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED NASALLY, XYLOCAINE SPRAY WAS USED AFTER INTUBATION AND FOUND OUT THAT THE PILOT BALLOON WAS DAMAGED. THE MARKS ON THE TUBE DISAPPEARED. REINTUBATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 11403818 ↗
• MalfunctionJan 14, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS AN ORAL TUBE BUT IT WAS INTUBATED NASALLY. THE SIZE WAS AS LARGE AS 8MM DESPITE OF NASAL I NTUBATION. THE CUFF WAS CLAMPED BY THE FORCEPS FOR TRACHEAL GUIDANCE AND IT WAS REPORTED THAT THE CUFF HAD INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11170115 ↗
• InjuryMay 18, 2020Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CUFF PRESSURE COULD NOT BE ADJUSTED AND WATER DROP WAS FOUND IN THE INFLATION LINE. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 10065558 ↗
• InjuryNov 27, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE UNIT VENTILATION VOLUME DECREASE ALARM WAS GENERATED AND CUFF CHECK WAS PERFORMED; HOWEVER, THE CUFF PRESSURE WAS APPROPRIATE. CUSTOMER STATED TUBE ABNORMALITY WAS SUSPECTED, ALTHOUGH PLACEMENT POSITION WAS CHECKED WITH FIBER, THERE WAS NO PROBLEM, THE CUFF LEAK WOULD NOT STOP, AND WATER WAS ALSO BEING POOLED IN THE INFLATION LINE HEAVILY, IT WAS JUDGED THAT THE CONDITION WAS UNMANAGEABLE AND THE TUBE WAS REPLACED. REINTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9387679 ↗
• InjuryNov 18, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS LEAKAGE IN THE CUFF. THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 9336652 ↗
• InjuryJun 28, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING INTUBATION, THE CUFF FOUND TO HAVE BREAKAGE, THE PATIENT REQUIRED RE-INTUBATION.

  Patient problems: Extubate

  MAUDE report 8746254 ↗
• InjuryJun 12, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW PRESSURE ALARM GENERATED DURING BREATHING MANAGEMENT. THERE WAS A FEELING LIKE THE CUFF DID NOT INFLATE. REINTUBATION WAS PERFORMED.

  Patient problems: Extubate

  MAUDE report 8691142 ↗
• MalfunctionJun 7, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION OR DEFLATION ISSUE. THE NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678416 ↗
• InjuryFeb 20, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, A MOISTURE WAS FOUND IN THE PILOT BALLOON, INFLATION LINE AND CUFF OF THE DEVICE. IT WAS STATED A SOUND WAS HEARD WHICH WAS DUE TO LEAK. THE CUSTOMER REPORTED PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8352972 ↗
• InjuryFeb 15, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, WHILE IN USE, A MOISTURE WAS FOUND IN THE PILOT BALLOON, INFLATION LINE AND CUFF OF THE DEVICE. IT WAS STATED THAT IT IS REPLACED BY TRACHEOSTOMY TUBE AND FOUND THAT TIP PART OF THAT DEVICE WAS BROKEN. THE CUSTOMER REPORTED PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8342824 ↗
• MalfunctionFeb 7, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A LIT OF MOISTURE BEYOND THE DEW CONDENSATION LEVEL INSIDE THE PILOT BALLOON. CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316291 ↗
• MalfunctionFeb 7, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, THEY FOUND THAT THERE WAS A LOT OF MOISTURE (BEYOND DUE TO CONDENSATION LEVEL) INSIDE THE PILOT BALLOON. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082520. One submission often covers many models, so check the product and lot details in each record.

• Z-1625-2016 · Apr 4, 2016 · Terminated
  Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
• Z-1626-2016 · Apr 4, 2016 · Terminated
  Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..