Shiley M5.0PDLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521554672), received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, ONE OF THE PAMPHLETS ON THE DEVICE STATED IT WAS FOR SINGLE USE ONLY, NOT TO CLEAN OR USE IT OVER 29 DAYS DUE TO THE DEHP. THE PATIENT WAS ALLERGIC TO MANY THINGS AND HAD PROBLEMS WITH EYES SWELLING UP WHEN THE DEVICE WAS USED. A DIFFERENT BRAND WAS USED BY THE PATIENT FOR 30 YEARS WITHOUT PROBLEM BUT IT WAS NO LONGER MANUFACTURED AND HAD TO USE OUR DEVICE. SWITCHING TO A DIFFERENT ONE WAS NOT POSSIBLE BECAUSE NO ONE WOULD MAKE A CUSTOM TRACH OUT OF PVC. THE CUSTOMER TRIED TO USE THE ONLY CUSTOM TRACH IN THE COUNTRY THAT WAS MADE FROM SILICON BIVONA BUT THE PATIENT DIED. IT WAS FOUND OUT THE PATIENT WAS HIGHLY ALLERGIC TO SILICON.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12069709 ↗

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