Shiley 5.5PEF (UDI 20884521101606)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521101606), received between Oct 10, 2021 and Sep 15, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K122531, K182861); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT IS IN A HOME SETTING WHEN THE FLANGE BROKE WHERE THE TRACH TIES ENTER TO SECURE THE TRACHEOSTOMY TUBE IN PLACE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432438 ↗
• MalfunctionApr 22, 2022Material Discolored; Patient Device Interaction Problem; Material Discolored; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD VOCAL CORD PARALYSIS. AFTER ONE WEEK OF CANNULA CHANGE, THE PATIENT¿S MOTHER WHO WAS TRAINED TO DO SO, FOUND A SMALL GRANULOMA/LESION AND NOTICED THE CANNULA WAS ORANGE IN COLOR WHILE DRESSING CHANGE AND WOUND CARE OF THE STOMA. THE INCIDENT HAPPENED AT HOME AND THE PATIENT'S MOTHER INFORMED THE NURSE. IT WAS REPORTED THAT THE CANNULA WAS REPLACED. NO FURTHER PATIENT COMPLICATION REPORTED.

  Patient problems: Granuloma; Unintended Extubation

  MAUDE report 14188468 ↗
• MalfunctionJan 6, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, "THE EYES TO WHICH THE CANNULA STRAPS ARE ATTACHED HAVE TEARS IN". THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13179134 ↗
• MalfunctionOct 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHILE HEALING AND CHANGING THE TAPE WAS CARRIED OUT AS USUAL, IT WAS FOUND OUT THAT THERE WAS A BREAK IN THE FLANGE. ANOTHER CANNULA WAS USED.

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

  MAUDE report 12602648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122531, K182861. One submission often covers many models, so check the product and lot details in each record.

• Z-1951-2015 · May 8, 2015 · Terminated
  Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.