Shiley 18780SRecalls & reported problems

Summary

The FDA's MAUDE database contains 251 adverse event reports that list this exact device (DI 10884521620209), received between Feb 6, 2018 and Sep 28, 2026 — classified as 24 injuries, 227 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (150 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 251 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923027 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50903384 ↗
• MalfunctionSep 24, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892005 ↗
• InjurySep 17, 2026Disconnection

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50810192 ↗
• InjurySep 17, 2026Disconnection

  Patient problems: Hypoxia; Unintended Extubation

  MAUDE report 50810074 ↗
• MalfunctionSep 4, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603757 ↗
• MalfunctionAug 20, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50359667 ↗
• MalfunctionAug 12, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223556 ↗
• MalfunctionAug 5, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147497 ↗
• MalfunctionJul 16, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847474 ↗
• MalfunctionJul 7, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE, AIR ENTERS THE CUFF, BUT IT DEFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738218 ↗
• MalfunctionJul 6, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD DIFFICULTY TO AIR INFLATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25721486 ↗
• MalfunctionJul 1, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF INFLATION AND DEFLATION WERE DIFFICULT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676839 ↗
• MalfunctionJun 25, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627784 ↗
• MalfunctionJun 9, 2026Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A LACERATION AT THE SLIP-JOINT CONNECTION IMMEDIATELY AFTER OPENING THE ENDOTRACHEAL TUBE'S PACKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25450717 ↗
• MalfunctionJun 5, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, WHEN AIR WAS INSERTED TO INFLATE THE ENDOTRACHEAL TUBE'S CUFF, THERE WAS QUITE A BIT OF RESISTANCE, AND ALSO WHEN BEING DEFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417343 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, AIR INFLATION AND DEFLATION OF THE CUFFS OF THE THREE ENDOTRACHEAL TUBES WERE STIFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671969 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, AIR INFLATION AND DEFLATION OF THE CUFFS OF THE THREE ENDOTRACHEAL TUBES WERE STIFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671965 ↗
• MalfunctionFeb 18, 2026Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF HAD A POOR INFLATION AND DEFLATION DURING THE PRE-USE INSPECTION IMMEDIATELY AFTER OPENING A NEW PRODUCT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381443 ↗
• MalfunctionFeb 13, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE A LEAK. IT WAS REPORTED THAT INFECTION WAS PRESENT BUT NOT RELATED TO THE DEVICE ISSUE. THE STERILIZATION METHOD WAS BEING CHECKED IN THE HOSPITAL. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24336278 ↗
• MalfunctionFeb 4, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PRE-USAGE INSPECTION, THE ENDOTRACHEAL TUBE HAD RESISTANCE HIGHER THAN USUAL WHEN AIR WAS PUMPED IN AND OUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262006 ↗
• MalfunctionJan 29, 2026Defective Component

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S ONE SIDE OF THE CUFF DID NOT INFLATE DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214913 ↗
• MalfunctionJan 27, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE ENDOTRACHEAL TUBE'S CUFF DOES NOT INFLATE SMOOTHLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192627 ↗
• MalfunctionJan 23, 2026Use of Device Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE "LUMP" OR ABNORMAL HARDNESS INSIDE THE CUFF OF THE ENDOTRACHEAL TUBE WAS NOTED AND IT DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172524 ↗
• MalfunctionJan 20, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD NO RING MARK OR X-RAY OPAQUE LINE AT THE TUBE TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126235 ↗