Shiley 76255Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 40884521157355), received between Sep 6, 2024 and May 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE ENDOTRACHEAL TUBE, WHEN PLACING THE MOUTH GAG FOR THE SURGERY, THE PLASTIC OF THE TUBE WAS DESCRIBED AS FLIMSIER AND MORE PRONE TO COLLAPSING AT THE TOP OF THE TUBE THAT CONNECTS TO THE GAS MACHINE CIRCUIT NEAR THE TUBE CONNECTOR. THE TUBE WAS REPOSITIONED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095624 ↗
• MalfunctionMay 27, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE ENDOTRACHEAL TUBE, WHEN PLACING THE MOUTH GAG FOR THE SURGERY, THE PLASTIC OF THE TUBE WAS DESCRIBED AS FLIMSIER AND MORE PRONE TO COLLAPSING AT THE TOP OF THE TUBE THAT CONNECTS TO THE GAS MACHINE CIRCUIT NEAR THE TUBE CONNECTOR. THE TUBE WAS REPOSITIONED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089797 ↗
• MalfunctionMay 27, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE ENDOTRACHEAL TUBE WHEN PLACING THE MOUTH GAG FOR THE SURGERY. THE PLASTIC OF THE TUBE WAS DESCRIBED AS FLIMSIER AND MORE PRONE TO COLLAPSING AT THE TOP OF THE TUBE THAT WAS CONNECTED TO THE GAS MACHINE CIRCUIT NEAR THE TUBE CONNECTOR. THE TUBE WAS REPOSITIONED ON THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089615 ↗
• MalfunctionMay 27, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE ENDOTRACHEAL TUBE, WHEN PLACING THE MOUTH GAG FOR THE SURGERY, THE PLASTIC OF THE TUBE WAS DESCRIBED AS FLIMSIER AND MORE PRONE TO COLLAPSING AT THE TOP OF THE TUBE THAT CONNECTS TO THE GAS MACHINE CIRCUIT NEAR THE TUBE CONNECTOR. THE TUBE WAS REPOSITIONED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087508 ↗
• MalfunctionSep 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194824 ↗
• MalfunctionSep 6, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ENDOTRACHEAL TUBE'S CUFF DID NOT DEPLOY WHEN ATTEMPTED TO INFLATE AFTER INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20156570 ↗