Shiley 96375Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 40884521157478), received between Jun 23, 2020 and Feb 13, 2024 — classified as 5 injuries, 1 malfunction.

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

• MalfunctionFeb 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE DEFLATES INSTANTANEOUSLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696464 ↗
• InjuryFeb 23, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE TUBE WAS MORE RIGID AND TRAUMATIC TO THE PATIENT, RESULTING IN NASAL INJURY AND BLEEDING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16431120 ↗
• InjuryNov 24, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PATIENT WAS REQUIRED NASAL INTUBATION. THE DEVICE (REA 7.5) PLACED AFTER GENERAL ANESTHESIA, DECONGESTANT, LUBRICATE NASAL TRUMPETS. CUFF OF EACH TUBE WAS TESTED AND LUBRICATED. NASAL-TRACHEAL INTUBATION ACHIEVED WITH VIDEO LARYNGOSCOPY-NOTHING UNUSUAL. FIRST DEVICE TUBE SEEMED TO FUNCTION NORMALLY, BUT AFTER 10MIN LOST CUFF PRESSURE AND WOULD NOT SUSTAIN PRESSURE. IT WAS REMOVED AND SECOND TUBE PLACED (SAME AND TESTED). IMMEDIATELY FOUND ALSO TO NOT RETAIN CUFF PRESSURE. IT WAS ALSO REMOVED AND THIRD TESTED AND PLACED WITH EXACT SAME FINDING. 6.5 ORAL ETT WAS PLACED WITH VIDEO LARYNGOSCOPY AND CARE PROCEEDED.

  Patient problems: Unintended Extubation

  MAUDE report 10898425 ↗
• InjuryNov 24, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PATIENT WAS REQUIRED NASAL INTUBATION. THE DEVICE (REA 7.5) PLACED AFTER GENERAL ANESTHESIA, DECONGESTANT, LUBRICATE NASAL TRUMPETS. CUFF OF EACH TUBE WAS TESTED AND LUBRICATED. NASAL-TRACHEAL INTUBATION ACHIEVED WITH VIDEO LARYNGOSCOPY-NOTHING UNUSUAL. FIRST DEVICE TUBE SEEMED TO FUNCTION NORMALLY, BUT AFTER 10MIN LOST CUFF PRESSURE AND WOULD NOT SUSTAIN PRESSURE. IT WAS REMOVED AND SECOND TUBE PLACED (SAME AND TESTED). IMMEDIATELY FOUND ALSO TO NOT RETAIN CUFF PRESSURE. IT WAS ALSO REMOVED AND THIRD TESTED AND PLACED WITH EXACT SAME FINDING. 6.5 ORAL ETT WAS PLACED WITH VIDEO LARYNGOSCOPY AND CARE PROCEEDED.

  Patient problems: Unintended Extubation

  MAUDE report 10898382 ↗
• InjuryNov 24, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PATIENT WAS REQUIRED NASAL INTUBATION. THE DEVICE (REA 7.5) PLACED AFTER GENERAL ANESTHESIA, DECONGESTANT, LUBRICATE NASAL TRUMPETS. CUFF OF EACH TUBE WAS TESTED AND LUBRICATED. NASAL-TRACHEAL INTUBATION ACHIEVED WITH VIDEO LARYNGOSCOPY-NOTHING UNUSUAL. FIRST DEVICE TUBE SEEMED TO FUNCTION NORMALLY, BUT AFTER 10MIN LOST CUFF PRESSURE AND WOULD NOT SUSTAIN PRESSURE. IT WAS REMOVED AND SECOND TUBE PLACED (SAME AND TESTED). IMMEDIATELY FOUND ALSO TO NOT RETAIN CUFF PRESSURE. IT WAS ALSO REMOVED AND THIRD TESTED AND PLACED WITH EXACT SAME FINDING. 6.5 ORAL ETT WAS PLACED WITH VIDEO LARYNGOSCOPY AND CARE PROCEEDED.

  Patient problems: Unintended Extubation

  MAUDE report 10898362 ↗
• InjuryJun 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S CUFF WOULD NOT INFLATE BECAUSE THE CUFF WAS PUNCTURED. PATIENT WAS REINTUBATED WITH NEW DEVICE.

  Patient problems: Extubate

  MAUDE report 10183482 ↗