SHERIDAN IPN926899Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704759887), received between Apr 13, 2023 and May 30, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2023Material Deformation; Material Deformation

  IT IS REPORTED THAT "OTHER REINFORCED ENDOTRACHEAL TUBES FROM THE SAME MANUFACTURER AND LOT ALSO KINK AND OBSTRUCT EASILY." NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019052 ↗
• InjuryMay 30, 2023Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT "AT END OF PRONE SURGERY WHEN TURNING SUPINE, PATIENT BIT ON THE REINFORCED TUBE RESULTING IN COMPLETE OCCLUSION OF THE AIRWAY. CUFF DEFLATED AS SOON AS POSSIBLE BUT PATIENT BECAME HYPOXIC, PROBABLY DUE TO NEGATIVE PRESSURE PULMONARY OEDEMA. ON EXAMINATION AFTER EXTUBATION THE REINFORCEMENT OF THE TUBE IS THIN AND INEFFECTIVE SO THE TUBE KINKS COMPLETELY, DEFEATING THE OBJECT OF USING REINFORCED TUBE". AS A RESULT, THE "PATIENT REQUIRED OVERNIGHT ADMISSION TO HOSPITAL AND SUPPLEMENTAL OXYGEN."

  Patient problems: Airway Obstruction

  MAUDE report 17019005 ↗
• MalfunctionApr 13, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT. INVOLVED 1 PC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733048 ↗