Shiley 86443Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30884522005696), received between Jul 18, 2017 and Jan 27, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Defective Component

  IT WAS REPORTED THAT A NEW ENDOTRACHEAL TUBE WAS FOUND WITH AN IMPROPER CUT ON THE END, LEAVING IT SHARP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196167 ↗
• MalfunctionSep 15, 2025Contamination /Decontamination Problem; Material Split, Cut or Torn; Contamination /Decontamination Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE LOOKS BURNT, HAD BLACK SUBSTANCE INSIDE AND OUTSIDE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A DAMAGE TUBE.

  Patient problems: Insufficient Information

  MAUDE report 23059151 ↗
• MalfunctionMay 6, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD A BROKEN CONNECTOR AND AIR INLET, PREVENTING CONNECTION TO THE FILTER AND OXYGEN CIRCUIT. BREAKAGE WAS IDENTIFIED UPON OPENING THE PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969812 ↗
• MalfunctionApr 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S PILOT BALLOON DID NOT INFLATE. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21857623 ↗
• InjuryJan 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE POST-OPERATIVE USE OF AN INTRANASAL 3.5 CUFFED ENDOTRACHEAL TUBE (ETT), THE TUBE SPLIT WHEN THE RESPIRATORY THERAPIST WAS PLACING THE ADAPTER TO PUT THE INLINE SUCTION INLINE. SPO2 WAS MAINTAINED IN THE UPPER 90'S DURING THE EVENT BUT HAD HYPOVENTILATION. THIS ISSUE OCCURRED TWICE, WITH THE SAME PROBLEM ARISING AFTER REINTUBATION WITH ANOTHER 3.5 ENDOTRACHEAL TUBE. REPLACEMENT OF THEE TUBE WAS DONE. THE PATIENT RECOVER WITHOUT OTHER DEVICE RELATED ISSUES.

  Patient problems: Hypoventilation; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 21180103 ↗
• InjuryJan 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE POST-OPERATIVE USE OF AN INTRANASAL 3.5 CUFFED ENDOTRACHEAL TUBE (ETT), THE TUBE SPLIT WHEN THE RESPIRATORY THERAPIST WAS PLACING THE ADAPTER TO PUT THE INLINE SUCTION INLINE. SPO2 WAS MAINTAINED IN THE UPPER 90'S DURING THE EVENT BUT HAD HYPOVENTILATION. THIS ISSUE OCCURRED TWICE, WITH THE SAME PROBLEM ARISING AFTER REINTUBATION WITH ANOTHER 3.5 ENDOTRACHEAL TUBE. REPLACEMENT OF THEE TUBE WAS DONE. THE PATIENT RECOVER WITHOUT OTHER DEVICE RELATED ISSUES.

  Patient problems: Hypoventilation; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 21176480 ↗
• MalfunctionSep 4, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENDOTRACHEAL TUBE'S PILOT VALVE WAS BROKEN, AND VERIFIED WITH A 3 ML SYRINGE WHERE THE SAME OCCURS. THE VALVE DID NOT INFLATE AND THE TUBE CHANGE WAS PERFORMED AND WORKED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136825 ↗
• InjuryOct 24, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE MARKING ON THE ENDOTRACHEAL TUBE CAME OFF IN ABOUT A WEEK WITH DAILY RETAPES. THE PATIENT HAD UNPLANNED EXTUBATION AND HARM POST EVENT AND THE MARKINGS NOT BEING PRESENT WAS A CONTRIBUTING FACTOR. A FULL RESUSCITATION WAS PERFORMED ON THE PATIENT.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 18000456 ↗
• MalfunctionAug 11, 2021Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TUBE REFERENCED CAME WITH THE CUFF INFLATOR DISCONNECTED AND CUT. ANOTHER TUBE FROM THE SAME LOT WAS CHECKED AND IT WAS FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306750 ↗
• InjuryFeb 5, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THEY WANTED THE CUFF TO BE DEFLATED AND THIS WAS DONE. IT WAS REPORTED THAT THE PILOT TUBE KEPT REINFLATING SPONTANEOUSLY. THE PATIENT WAS TOO UNSTABLE TO CHANGE THE TUBE OUT SO THEY CUT THE PILOT TUBE TO ENSURE THE CUFF WAS DEFLATED. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 9670692 ↗
• MalfunctionJan 2, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE POINT OF THE TUBE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9538799 ↗
• MalfunctionApr 18, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8526923 ↗
• MalfunctionJul 18, 2017Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED REPORT THAT, PRIOR TO USE, THE PILOT BALLOON LINE WAS FOUND TO BE CUT. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6721752 ↗