Shiley 5.5 PEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 30884522026745), received between Jun 29, 2017 and May 5, 2022 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K945513); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE CANNULA RUPTURED IN UNION WITH FASTENERS. THE MOTHER REPORTED THAT THE PRODUCT WAS BROKEN AT 3 MONTHS, NOW IT IS BROKEN AT 1 1/2 MONTHS. IT HAS CHANGED 4 CANNULAS SINCE THAT TIME.

  Patient problems: Unintended Extubation

  MAUDE report 14287135 ↗
• MalfunctionMay 4, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE CANNULA RUPTURED IN UNION WITH FASTENERS. THE MOTHER REPORTED THAT THE PRODUCT WAS BROKEN AT 3 MONTHS, NOW IT IS BROKEN AT 1 1/2 MONTHS. IT HAS CHANGED 4 CANNULAS SINCE THAT TIME.

  Patient problems: Unintended Extubation

  MAUDE report 14284181 ↗
• MalfunctionMay 4, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE CANNULA RUPTURED IN UNION WITH FASTENERS. THE MOTHER REPORTED THAT THE PRODUCT WAS BROKEN AT 3 MONTHS, NOW IT IS BROKEN AT 1 1/2 MONTHS. IT HAS CHANGED 4 CANNULAS SINCE THAT TIME.

  Patient problems: Unintended Extubation

  MAUDE report 14284132 ↗
• MalfunctionApr 19, 2022Connection Problem; Material Split, Cut or Torn; Connection Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CANNULA RUPTURED IN UNION WITH FASTENERS. THE MOTHER REPORTED THAT THE PRODUCT WAS BROKEN AT 3 MONTHS, NOW IT IS BROKEN AT 1 1/2 MONTHS. IT HAS CHANGED 4 CANNULAS SINCE THAT TIME.

  Patient problems: Unintended Extubation

  MAUDE report 14142520 ↗
• MalfunctionOct 14, 2019Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BLACK COLORING FOUND AT 2 CM FROM THE TIP WHEN THE TUBE WAS EXCHANGED. IT WAS STATED THAT THE TRACHEA WAS CLEAN INSIDE AND NO BLACK STAIN OR LESION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186076 ↗
• MalfunctionOct 14, 2019Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BLACK COLORING FOUND AT 1 CM FROM THE FLANGE. IT WAS STATED THAT THE TRACHEA WAS CLEAN INSIDE AND NO BLACK STAINS OR LESION. THE CUSTOMER INDICATED NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9183993 ↗
• MalfunctionSep 16, 2019Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BLUISH STAINED COLOUR FOUND ON THE TUBE AFTER ONE DAY OF USED. IT WAS INDICATED THAT ANOTHER DEVICE WAS USED AND FOUND BLUISH COLOUR ON THE TUBE AFTER TWO DAYS.

  Patient problems: No Information

  MAUDE report 9072487 ↗
• InjurySep 15, 2019Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BLUISH STAINED COLOR FOUND ON THE TUBE AFTER ONE DAY OF USED. IT WAS INDICATED THAT ANOTHER DEVICE WAS USED AND FOUND THE BLUISH COLOR ON THE TUBE AFTER TWO DAYS.

  Patient problems: Extubate

  MAUDE report 9068386 ↗
• InjurySep 15, 2019Material Discolored; Material Discolored

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  Patient problems: Extubate

  MAUDE report 9068375 ↗
• MalfunctionAug 7, 2017Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE CANNULA FIXING LOOP BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6770025 ↗
• MalfunctionAug 7, 2017Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE CANNULA FIXING LOOP BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6770022 ↗
• MalfunctionJun 29, 2017Cut In Material; Split; Cut In Material; Split

  MEDTRONIC RECEIVED A REPORT WHERE IT WAS ALLEGED THAT THERE WAS A BREAKAGE ON PILOT VALVE. THERE IS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6679765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945513. One submission often covers many models, so check the product and lot details in each record.

• Z-0997-2009 · Jan 14, 2009 · Terminated
  Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The pr