Shiley 96370Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 40884521157461), received between Sep 16, 2019 and Feb 25, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE USED HAD CUFF INFLATION OR DEFLATION. A TUBE FROM ANOTHER BRAND WAS USED.

  Patient problems: Unintended Extubation

  MAUDE report 21465589 ↗
• InjuryApr 28, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF OF THE DEVICE HAD INFLATION/DEFLATION ISSUE. THE PATIENT HAD A 3 REPLACEMENT OF THE TUBE. THE FIRST 2 TUBE HAD A BALLOON THAT COULD NOT INFLATE WHILE THE THIRD TUBE COULD INFLATE BUT THE SYSTEM DID NOT KEEP THE AIR INSIDE THE BALLOON. THE LINE OF THE THIRD TUBE WAS CLAMPED OF INSUFFLATION TO KEEP THE AIR IN THE BALLOON CONSTANT AND USE THAT AS THE FINAL TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14232964 ↗
• MalfunctionApr 28, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF OF THE DEVICE HAD INFLATION/DEFLATION ISSUE. THE PATIENT HAD A 3 REPLACEMENT OF THE TUBE. THE FIRST 2 TUBE HAD A BALLOON THAT COULD NOT INFLATE WHILE THE THIRD TUBE COULD INFLATE BUT THE SYSTEM DID NOT KEEP THE AIR INSIDE THE BALLOON. THE LINE OF THE THIRD TUBE WAS CLAMPED OF INSUFFLATION TO KEEP THE AIR IN THE BALLOON CONSTANT AND USE THAT AS THE FINAL TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 14232745 ↗
• MalfunctionApr 28, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF OF THE DEVICE HAD INFLATION/DEFLATION ISSUE. THE PATIENT HAD A 3 REPLACEMENT OF THE TUBE. THE FIRST 2 TUBE HAD A BALLOON THAT COULD NOT INFLATE WHILE THE THIRD TUBE COULD INFLATE BUT THE SYSTEM DID NOT KEEP THE AIR INSIDE THE BALLOON. THE LINE OF THE THIRD TUBE WAS CLAMPED OF INSUFFLATION TO KEEP THE AIR IN THE BALLOON CONSTANT AND USE THAT AS THE FINAL TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 14232703 ↗
• MalfunctionMar 23, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF OF THE DEVICE HAD INFLATION/DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 13860954 ↗
• MalfunctionNov 16, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A FRAGILE AND PIERCED CUFFS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844091 ↗
• MalfunctionNov 16, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A FRAGILE AND PIERCED CUFFS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844074 ↗
• MalfunctionNov 13, 2020Fluid/Blood Leak; Material Separation; Use of Device Problem; Fluid/Blood Leak; Material Separation; Use of Device Problem

  ACCORDING TO THE REPORTER, A LEAK WAS NOTICED BY THE ANESTHESIOLOGISTS AFTER A NASO-TRACHEAL INTUBATION. THE DEVICE HAD A HOLE IN THE TUBE. THE PATIENT WAS EXTUBATED THEN RE-INTUBATED WITH ANOTHER TUBE.

  Patient problems: No Patient Involvement; Unintended Extubation

  MAUDE report 10835384 ↗
• InjuryMar 9, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF HAD FAILED UPON INFLATION ON BOTH DEVICES. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Extubate; No Information

  MAUDE report 9807373 ↗
• InjuryMar 9, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF HAD FAILED UPON INFLATION ON BOTH DEVICES. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Extubate; No Information; Unintended Extubation

  MAUDE report 9805092 ↗
• InjuryOct 4, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT NEED TO HAVE THE ENDOTRACHEAL TUBE (ETT) CHANGED THEN THE CUFF LEAKED. THE DOCTOR DECIDED TO HAVE THE PATIENT EXTUBATED AS TRIAL AND HE DID WELL. THE PATIENT HAD TO BE RE-INTUBATED AND THE ETT FAILED TWICE. AFTER THE SECOND FAILED TUBE, PATIENT WAS PLACED ON A BIPAP. HE PROGRESSED WELL AND WAS DISCHARGED FOR THE HOSPITAL.

  Patient problems: Extubate

  MAUDE report 9156520 ↗
• InjurySep 16, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT NEED TO HAVE THE ENDOTRACHEAL TUBE (ETT) CHANGED THEN THE CUFF LEAKED. THE DOCTOR DECIDED TO HAVE THE PATIENT EXTUBATED AS TRIAL AND HE DID WELL. THE PATIENT HAD TO BE RE-INTUBATED AND THE ETT FAILED TWICE. AFTER THE SECOND FAILED TUBE, PATIENT WAS PLACED ON A BIPAP. HE PROGRESSED WELL AND WAS DISCHARGED FOR THE HOSPITAL.

  Patient problems: Extubate

  MAUDE report 9072129 ↗