Shiley 3.0 PEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884522026691), received between Sep 27, 2017 and Jan 8, 2019 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE INK NUMBERING IN THE UNIT WAS WEARING OFF. IT IS THEIR COMMON PRACTICE TO RE-TAPE THE DEVICE TO THEIR PATIENT EVERY OTHER DAY CAUSING THE NUMBERS/INK TO WEAR OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8228618 ↗
• InjuryOct 25, 2018Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  ACCORDING TO THE REPORTER, THERE WAS YELLOW STAIN ON THE TRACHEOSTOMY TUBE. CUSTOMER INDICATED DECANNULATION/REINTUBATION WAS REQUIRED OR PERFORMED.

  Patient problems: Extubate

  MAUDE report 8004864 ↗
• DeathSep 27, 2017Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED A REPORT THAT THE MANUAL OR INSTRUCTIONS (IFU) DO NOT CLEARLY DESCRIBE HOW TO USE THE MEDICAL DEVICE. IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF BRADYCARDIA. PATIENT WAS PREMATURE MALE (B)(6) KG AND THE PATIENT'S MOTHER HAD A KNOWN INFECTION. THE CUSTOMER REPORTED THAT THE DEVICE WAS PLACED IMPROPERLY. IT WAS REPORTED THAT LATER AT AN UNSPECIFIED DATE AND TIME THE PATIENT DIED, AND THE DEATH WAS UNRELATED TO THIS DEVICE AND EVENT. THE CUSTOMER NOTED THAT THE PRODUCT WAS DESTROYED.

  Patient problems: Death

  MAUDE report 6898917 ↗

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