Shiley 4.5 PEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30884522026721), received between Jun 13, 2017 and Sep 20, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA'S FLANGE HAD A TEAR AT THE OUTER EDGE, RELEASING THE TIE-DOWN TAPE, THAT MADE IT IMPOSSIBLE TO FIX THE TUBE BASED ON THE PHOTO PROVIDE, DURING USE. AN ENTIRE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17782015 ↗
• MalfunctionJul 21, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACH'S NECK FLANGE TAPE HOLDER WAS BROKEN DURING USE (SEE PHOTO). THE PATIENT HAD A REPLACEMENT OF THE TUBE.

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

  MAUDE report 17375053 ↗
• MalfunctionJul 21, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACH'S NECK FLANGE TAPE HOLDER WAS BROKEN DURING USE. THERE WAS NO PATIENT HARM.

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

  MAUDE report 17375024 ↗
• MalfunctionMar 3, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT NECK FLANGE GOT DAMAGED AND CAME OFF FROM THE TUBE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404548 ↗
• MalfunctionMar 3, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A DAMAGED NECK FLANGE. THE PATIENT HAD AN INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404435 ↗
• InjuryApr 8, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE SHAFT OF TRACHEOSTOMY TUBE WAS NOT AT THE CORRECT ANGLE/STRAIGHT. IT WAS REPORTED THAT THE TUBE SITTING HIGHER THAN NORMAL UNDER THE CHIN. THE PATIENT BEGAN COUGHING ALMOST IMMEDIATELY AFTER INSERTION OF TRACHEOSTOMY TUBE AND STATED PAIN. THIS LASTED ABOUT 1 HOUR BEFORE TRACHEOSTOMY TUBE WAS CHANGED. SYMPTOMS CEASED IMMEDIATELY ONCE TRACHEOSTOMY WAS CHANGED.

  Patient problems: Extubate

  MAUDE report 9937103 ↗
• MalfunctionAug 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, WHEN THE OBTURATOR ASSOCIATED WITH TRACHEOSTOMY TUBE WAS ATTEMPTED TO BE ATTACHED, THE OBTURATOR WAS NOT SMOOTH AND WAS UNABLE TO BE ENTERED. IT WAS TRIED TO ATTACH THE OBTURATOR BY SEVERAL NURSES AND DOCTORS, IT COULD BE ATTACHED, BUT THE REMOVAL OF THE OBTURATOR WAS NOT SMOOTH EITHER AND WAS HARD TO BE PERFORMED, SO THE PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8921952 ↗
• InjuryAug 20, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S NECK FLANGE WAS TORE AFTER 10 DAYS OF USE. THE CUSTOMER INDICATED THAT THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 7797257 ↗
• MalfunctionJun 13, 2017Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED A REPORT THE NECK OF THE CANNULA WAS BROKEN. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6638412 ↗

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