Shiley 18750Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 60884522007530), received between Dec 18, 2018 and Mar 31, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USE TESTING OF THE ENDOTRACHEAL TUBE, THE CUFF WAS TESTED WITH A SYRINGE AND A CUFF PRESSURE GAUGE BUT THE CUFF DID NOT INFLATE OR DEFLATE AS EXPECTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737943 ↗
• MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785489 ↗
• MalfunctionAug 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE ENDOTRACHEAL TUBE'S CUFF HAD LEAKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751501 ↗
• MalfunctionJul 5, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PILOT LINE WAS OFF FROM THE ENDOTRACHEAL TUBE. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19684204 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR USE, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313282 ↗
• MalfunctionSep 19, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE CONNECTOR TUBE WAS LOOSE AND EASILY DETACHES FROM THE ENDOTRACHEAL TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774510 ↗
• MalfunctionMay 8, 2022Component Missing; Connection Problem; Component Missing; Connection Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE MATERIAL CAME WITHOUT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332529 ↗
• MalfunctionAug 18, 2021Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, WHEN THE CUFF WAS INFLATED, THE AIR LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337783 ↗
• MalfunctionOct 30, 2020Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION AND DEFLATION ISSUE. THE CUFF LEAK WAS DETECTED BEFORE USE ON PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10762499 ↗
• InjuryApr 17, 2019Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, THE UNIT'S TUBE WAS BENT. THE PATIENT PRESENTED ALVEOLAR HYPOVENTILATION AND A REPLACEMENT OF THE TUBE HAS BEEN DONE TO GUARANTEE THE VENTILATION.

  Patient problems: Extubate

  MAUDE report 8523410 ↗
• InjuryDec 18, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE TUBE PRESENTED FOLD IN THE FIRST MARKING THUS CREATING (MEMORY), MAKING IT DIFFICULT FOR THE PATIENT'S BREATHING. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8176102 ↗