Shiley 86453Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884522000493), received between Oct 31, 2020 and Nov 18, 2020 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathNov 18, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF BREAKAGE. PATIENTS HAD BEEN INTUBATED, IT WAS MENTIONED THAT IT WAS A COVID PATIENT IN CRITICAL CARE WITH CO-MORBIDITIES. IT WAS INDICATED THAT THEY TAKEN OFF THE VENT AT THE REQUEST OF THE FAMILY DUE TO THE SEVERITY OF CONDITION AND OTHER CO-MORBIDITIES THAT THE PATIENT HAD AND DIED AS A RESULT.

  Patient problems: Insufficient Information

  MAUDE report 10861054 ↗
• InjuryNov 12, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF BREAKAGE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 10829444 ↗
• DeathOct 31, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF BREAKAGE. PATIENTS HAD BEEN INTUBATED, IT WAS MENTIONED THAT IT WAS A COVID PATIENT IN CRITICAL CARE WITH CO-MORBIDITIES. IN ADDITION PATIENT WAS TRANSFERRED TO A HIGHER LEVEL CRITICAL CARE HOSPITAL WHERE LATER DIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10767487 ↗