Shiley 5.0 PEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30884522026738), received between Jun 5, 2018 and Sep 18, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA HAD A SLIP JOINT AT THE 15-MM CONNECTOR PART. THE COUPLING WAS LOOSE WITH THE CATHETER-MOUNT ROTATING CONNECTOR. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17763199 ↗
• MalfunctionSep 18, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA HAD A SLIP JOINT AT THE 15-MM CONNECTOR PART. THE COUPLING WAS LOOSE WITH THE CATHETER-MOUNT ROTATING CONNECTOR. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17763186 ↗
• InjuryDec 30, 2019Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, THE UNIT HAD ALWAYS BEEN PASSED TO THE PATIENT FROM THE HOSPITAL, BUT THE PATIENT POINTED OUT THAT A PINKISH STAIN WAS FOUND TO BE ATTACHED AROUND THE BASE OF THE ACTUAL PRODUCT. RECANNULATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9529988 ↗
• MalfunctionJul 10, 2018Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE IN USE ON A PATIENT, THE TUBING WAS FIXED WITH TWO HAND MADE BAND WITH FRINGE, THE FRINGE WAS BROKEN AND THE BAND WAS DETACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673458 ↗
• MalfunctionJun 5, 2018Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE'S CANNULA FLANGE WAS TORE EASILY. THE CUSTOMER INDICATED NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571135 ↗

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