Shiley 86232 (UDI 10884521620230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521620230), received between Sep 2, 2019 and Feb 28, 2024 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Defective Component” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SIX DIFFERENT ENDOTRACHEAL TUBES WITH UNIDENTIFIED AFFECTED QUANTITY HAD A GENERAL COMPLAINT ABOUT QUALITY AND TEXTURE THAT CAUSED TRAUMA TO THE NASAL PASSAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18803642 ↗
• MalfunctionNov 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE FIRST ENDOTRACHEAL TUBE HAD CUFF INFLATION AND DEFLATION ISSUES, AND THE OTHER ENDOTRACHEAL TUBE HAD CUFF BREAKAGE. IT WAS ALSO REPORTED THAT THE SKIN STAPLER HAD A MALFUNCTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075109 ↗
• MalfunctionMar 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE WAS DAMAGED DURING INTUBATION AND WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 16553380 ↗
• MalfunctionFeb 17, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PILOT VALVE OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553078 ↗
• InjurySep 15, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AN INFANT WAS INTUBATED IN DELIVER ROOM. WHEN THE INFANT WAS PLACED ON THE WARMER BED, THE VITAL SIGN DETERIORATED. WHEN CHECKED THE DEVICE PLACEMENT, IT WAS IN THE ESOPHAGUS. THE TUBE WAS PULLED, PATIENT WAS BAGGED AND NEW TUBE WAS PLACED. WHEN TURNING THE PATIENT IN BED AFTER TAPING THE TUBE, IT WAS FOUND THE TUBE WAS SPLIT. THE TUBE WAS TRIMMED TO PREVENT FURTHER SPLITTING AND ATTACHED TO THE JET WITH GREAT DIFFICULTY. THE TUBE KEPT DISCONNECTING FROM THE VENT OVERNIGHT SO PATIENT WAS RE-INTUBATED THE FOLLOWING DAY.

  Patient problems: Extubate

  MAUDE report 10535912 ↗
• InjuryAug 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AN INFANT WAS INTUBATED IN DELIVER ROOM. WHEN THE INFANT WAS PLACED ON THE WARMER BED, THE VITAL SIGN DETERIORATED. WHEN CHECKED THE DEVICE PLACEMENT, IT WAS IN THE ESOPHAGUS. THE TUBE WAS PULLED, PATIENT WAS BAGGED AND NEW TUBE WAS PLACED. WHEN TURNING THE PATIENT IN BED AFTER TAPING THE TUBE, IT WAS FOUND THE TUBE WAS SPLIT. THE TUBE WAS TRIMMED TO PREVENT FURTHER SPLITTING AND ATTACHED TO THE JET WITH GREAT DIFFICULTY. THE TUBE KEPT DISCONNECTING FROM THE VENT OVERNIGHT SO PATIENT WAS RE-INTUBATED THE FOLLOWING DAY.

  Patient problems: Extubate

  MAUDE report 10468351 ↗
• InjuryAug 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, AN INFANT WAS INTUBATED IN DELIVERY ROOM. WHEN THE INFANT WAS PLACED ON THE WARMER BED, THE VITAL SIGN DETERIORATED. WHEN CHECKED THE DEVICE PLACEMENT, IT WAS IN THE ESOPHAGUS. THE TUBE WAS PULLED, PATIENT WAS BAGGED AND NEW TUBE WAS PLACED. WHEN TURNING THE PATIENT IN BED AFTER TAPING THE TUBE, IT WAS FOUND THE TUBE WAS SPLIT. THE TUBE WAS TRIMMED TO PREVENT FURTHER SPLITTING AND ATTACHED TO THE JET WITH GREAT DIFFICULTY. THE TUBE KEPT DISCONNECTING FROM THE VENT OVERNIGHT SO PATIENT WAS RE-INTUBATED THE FOLLOWING DAY.

  Patient problems: Extubate

  MAUDE report 10468201 ↗
• InjuryAug 27, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT HAD SPLIT DOWN THE SIDE OF THE TUBE WHEN A BUNNEL JET LIFE PORT ADAPTER WAS PLACED IN THE END. THE PART THAT SPLIT WAS AT THE END OF THE TUBE WHERE THE BEVEL PORTION OF THE 15MM ADAPTER FITS INTO THE ENDOTRACHEAL TUBE (ETT) ITSELF. THERE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 10461762 ↗
• MalfunctionAug 14, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD SPLIT DOWN THE SIDE OF THE TUBE WHEN ADAPTER WAS PLACED IN THE END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10407824 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953654 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953647 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953646 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953643 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953530 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953529 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953517 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953510 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953478 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953475 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953472 ↗