Shiley 110875Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 40884521068224), received between Jun 17, 2019 and Jun 26, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, SHORTLY AFTER INTUBATION, THE NURSE NOTICED FLUID INSIDE THE ENDOTRACHEAL TUBE'S PILOT BALLOON, AND ABOUT 1/4 OF THE VOLUME WAS FILLED WITH FLUID DURING USE. THE CUFF PRESSURE WAS GOOD, AND THERE WAS NO OTHER DAMAGE NOTICED. IT WAS STATED THAT INITIALLY THE CUFF WAS FILLED WITH A NEW AND DRY SYRINGE, BUT IT WAS UNKNOWN IF THERE WAS LIQUID INSIDE THE CUFF TOO. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19619991 ↗
• MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON AND INFLATION LINE HAD ACCUMULATED DROPLETS OF WATER DURING PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18714656 ↗
• 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 13417809 ↗
• MalfunctionNov 24, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WAS UNABLE TO INJECT AIR OR REMOVED AIR SO A HOLE WAS MADE IN THE PILOT BALLOON TO DEFLATE. REPLACEMENT WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 12868614 ↗
• MalfunctionMar 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE WATER DROPLETS WERE GENERATED IN THE CUFF AND CUFF PRESSURE COULD NOT BE CONTROLLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462048 ↗
• InjurySep 25, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A CONDENSATION ON THE PILOT BALLOON AND 1.4 CC WAS COLLECTED AFTER A WEEK OF INTUBATION. WHEN THEY TRIED TO SUCTION AFTER 5 DAYS, 1 CC WAS ABLE TO BE SUCTION. THEY SUCTIONED 3.2 ML OF WATER IN THE CUFF ON JULY 12, 3 ML ON AUGUST 19, AND 0.5 ML ON AUGUST 22. THEY REPLACED IT WITH A CUSTOM-MADE TUBE.

  Patient problems: Extubate

  MAUDE report 9115591 ↗
• MalfunctionJun 17, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8706165 ↗
• MalfunctionJun 17, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8706164 ↗

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..