Shiley 18870 (UDI 30884521750344)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30884521750344), received between Feb 19, 2025 and Jul 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN CHECKING THE TRACHEAL TUBE, IT WAS FOUND THAT THE CUFF WAS LEAKING, AND A NEW TRACHEAL TUBE WAS REPLACED FOR THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD A MINOR INJURY.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 22449485 ↗
• MalfunctionFeb 19, 2025Material Separation; Connection Problem; Material Split, Cut or Torn; Material Separation; Connection Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN ENDOTRACHEAL TUBE, THERE WAS A BREAKAGE AT THE END OF THE TUBE. THE ISSUE OCCURRED WHEN ATTEMPTING TO ADVANCE A SUCTION CATHETER DOWN THE TUBE, RESULTING IN A SNAPPING SOUND AND THE END OF THE TUBE BROKE. ASSISTANCE WAS CALLED, AND A SECOND NURSE HELD THE TUBE TOGETHER WHILE THE PATIENT MAINTAINED GOOD VOLUMES AND OXYGEN SATURATION OF ABOVE 95%. THE CONNECTOR WAS DIFFICULT TO DETACH AND SNAPPED COMPLETELY DURING REPLACEMENT ATTEMPTS. CONSEQUENTLY, THE TUBE WAS CUT BEYOND THE LENGTH OF THE CONNECTOR, AND A NEW ONE WAS ATTACHED, SUCCESSFULLY CONNECTING THE PATIENT TO THE VENTILATOR. TIDAL VOLUMES AND SATURATION REMAINED WITHIN NORMAL RANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 21410556 ↗