Shiley M4.0PEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521555259), received between Dec 30, 2019 and Dec 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (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.

• MalfunctionDec 30, 2019Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, DURING USE, THE TOP OF THE DEVICE AND THE CONNECTOR TURNED BLUE. PATIENT HAD AN INFECTION, WHICH CAUSED THE DISCOLORATION OF THE TRACH TUBE. THE PATIENT WAS GIVEN THE REPLACEMENT TRACH TUBE. THERE WAS NO RECANNULATION PERFORMED TO THE PATIENT.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 9529005 ↗

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