Shiley 86395Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884522002042), received between Jan 4, 2021 and Oct 30, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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.

• MalfunctionOct 30, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE LABEL THAT WAS ON THE 15 MM CONNECTOR HAD STARTED TO PEEL ON THE EDGES PRIOR TO REMOVING FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430015 ↗
• MalfunctionAug 10, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE LASER TUBE LEAKING AIR DISTALLY ON THE METAL TUBE. THE PATIENT WAS EXTUBATED AND REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 15202608 ↗
• MalfunctionAug 10, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE LASER TUBE LEAKING AIR DISTALLY ON THE METAL TUBE. THE PATIENT WAS EXTUBATED AND REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 15202508 ↗
• MalfunctionMay 10, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD AN AIR LEAK THAT WOULD CAUSE COMBUSTION IF IT COMES INTO CONTACT WITH THE LASER, IT WAS PERFORMED UNDER APNEA TO CONTINUED THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801315 ↗
• MalfunctionMar 30, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A LEAKAGE THAT WAS COMING FROM THE "COLLAR" OF THE CUFF AREA (THE JUNCTION OF TWO PIECES OF METAL IN THE TUBE), AND THEY HAVE NOT BEEN GRASPED/MANIPULATED WITH FORCEPS OR ANY OTHER METAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11589809 ↗
• MalfunctionJan 4, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A LEAKAGE THAT WAS COMING FROM THE "COLLAR" OF THE CUFF AREA (THE JUNCTION OF TWO PIECES OF METAL IN THE TUBE), AND THEY HAVE NOT BEEN GRASPED/MANIPULATED WITH FORCEPS OR ANY OTHER METAL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11109123 ↗