Shiley 4.0 PEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30884522026714), received between Jun 28, 2018 and Feb 15, 2024 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS CAUSING THE PATIENT TO COUGH AFTER JUST AN HOUR AND WAS REPLACED WITH A DIFFERENT TYPE OF TRACH.

  Patient problems: Unintended Extubation

  MAUDE report 18717850 ↗
• MalfunctionFeb 23, 2023Defective Component; Connection Problem; Defective Component; Connection Problem

  ACCORDING TO THE REPORTER, THE CONNECTOR OF THE DEVICE WAS TOO RIGID AND COULD NOT BE CONNECTED TO THE CATHETER MOUNT DURING PLACEMENT WITH NO VISIBLE DAMAGED ON BOTH. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 16427855 ↗
• MalfunctionJul 14, 2021Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS ATTACHED TO AN ARTIFICIAL NOSE (SPONTANEOUS) BUT THE CONNECTION TO THE CONNECTOR WAS STIFF AND HAD A DIFFICULTY TO DISCONNECT. THE PATIENT HAD A REPLACEMENT OF THE TUBE WITHOUT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 12167927 ↗
• MalfunctionMar 4, 2021Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT WAS APPROXIMATELY 2MM SHORTER THAN SPECIFICATION. ANOTHER PRODUCT HAD A BENT CANNULA INTERNALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11410828 ↗
• MalfunctionSep 28, 2020Material Separation; Material Separation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TUBE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10592324 ↗
• MalfunctionOct 7, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A STRONG RESISTANCE FELT WHEN REMOVING THE OBTURATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9161157 ↗
• InjuryNov 13, 2018Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, THE CANNULA'S WINGS HAD A SHARP EDGE THAT DAMAGED THE SKIN ON THE PATIENT¿S NECK.

  Patient problems: Injury

  MAUDE report 8065538 ↗
• InjuryNov 13, 2018Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, THE CANNULA'S WINGS HAD A SHARP EDGE THAT DAMAGED THE SKIN ON THE PATIENT¿S NECK.

  Patient problems: Injury

  MAUDE report 8065532 ↗
• InjuryOct 1, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DAMAGED FASTENING FLAP. THE CUSTOMER REPORTED THAT THE PATIENT PRESENTED EXTREME BRADYCARDIA.

  Patient problems: Injury

  MAUDE report 7922674 ↗
• InjuryOct 1, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DAMAGED FASTENING FLAP. THE CUSTOMER REPORTED THAT THE PATIENT PRESENTED EXTREME BRADYCARDIA.

  Patient problems: Injury

  MAUDE report 7922620 ↗
• InjuryAug 29, 2018Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE HAD PHYSICAL DAMAGE AND THE FLANGE WAS BROKEN. IT WAS REPORTED THAT DURING NURSING PROCEDURE, THE PATIENT WAS RESTLESS AND MADE A SUDDEN MOVEMENT AND BROKE THE LEFT FIN OF THE CANNULA. THE CUSTOMER REPORTED THAT THE PATIENT REQUIRED RE-CANNULATION.

  Patient problems: Extubate

  MAUDE report 7828288 ↗
• MalfunctionJul 6, 2018Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, PRIOR TO USE, TUBING WAS DISCOLORED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7666733 ↗
• InjuryJun 28, 2018Device Markings/Labelling Problem; Device Packaging Compromised; Device Markings/Labelling Problem; Device Packaging Compromised

  ACCORDING TO THE REPORTER, THE DEVICE HAD WRONG TRACHEOSTOMY TUBE INSIDE THE BOX, THEY FOUND A SIZE 6 TRACHEOSTOMY TUBE INSIDE THE SIZE 4 TRACHEOSTOMY BOX. IT WAS INDICATED THAT THE UNIT WAS NOT STERILE BECAUSE THE BOX WAS NOT SEALED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A SEVERE DISCOMFORT DUE TO THE LARGER SIZE OF THE TUBE THAN THE STOMA SITE. THE CUSTOMER REPORTED THAT THEY REPLACED THE TUBE FROM SIZE 6 TO SIZE TO SIZE 4.

  Patient problems: Extubate

  MAUDE report 7645839 ↗

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