Shiley 18780Recalls & reported problems

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 10884522007610), received between Oct 23, 2017 and Sep 17, 2026 — classified as 3 deaths, 34 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (132 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 286 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Use of Device Problem

  It was reported that, the two endotracheal tube had an inflation/deflation issue prior to use in a hospital setting. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802258 ↗
• MalfunctionSep 16, 2026Use of Device Problem

  It was reported that, the two endotracheal tube had an inflation/deflation issue prior to use in a hospital setting. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787369 ↗
• MalfunctionAug 30, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510312 ↗
• MalfunctionAug 7, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177613 ↗
• MalfunctionJul 31, 2026Disconnection

  It was reported that during use, the endotracheal tube's hub had repeatedly came out. Tube was replaced but also had similar hub sep aration issue. Tube was again replaced, and no apparent issue since.

  Patient problems: Unintended Extubation

  MAUDE report 50098671 ↗
• MalfunctionJul 30, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083247 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED NINETEEN MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678860 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678656 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED NINETEEN MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678586 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678574 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED NINETEEN MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678558 ↗
• MalfunctionMar 24, 2026Human-Device Interface Problem; Material Deformation

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE BECAME SOFT AND KINKED AFTER APPROXIMATELY TWO DAYS OF USAGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24678528 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678517 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED NINETEEN MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678441 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678142 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678113 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671945 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED NINETEEN MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671924 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED NINETEEN MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671900 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671821 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED NINETEEN MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671802 ↗
• MalfunctionMar 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671524 ↗
• MalfunctionMar 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671485 ↗
• MalfunctionMar 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671469 ↗
• MalfunctionMar 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, BASED ON THE ATTACHED PHOTO, ONE PILOT BALLOON WAS DEFORMED IN THE PACKAGING. WHEN THE CUFF WAS INFLATED TO THE CORRECT PRESSURE, THESE BLUE CUFF REMAINED DENTED ON THE OUTSIDE, MAKING IT APPEARED THAT IT WAS NOT PROPERLY INFLATED, AND THE CUFF MEASUREMENTS WAS INCORRECT. AFTERWARD, THE TEAM OPENED TWENTY TWO MORE DEVICES AND FOUND THAT THE SAME PROBLEM WAS PRESENTED IN THE TUBES THAT WERE STILL INSIDE THEIR PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671462 ↗