Shiley M4PT (UDI 10884521554573)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521554573), received between Nov 23, 2021 and Nov 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionNov 23, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE SIZE WAS THE SAME BUT THE AREA AROUND THE HOLE WAS LARGER, WIDER AND LONGER SO THE VENTILATOR ADAPTOR WOULD NOT STAYED ON. IT WAS REPORTED THAT THERE WAS A DIFFERENCE ON THE SIZE OF THE FLANGE, THE OLD DEVICE WAS EXTRA-LONGER IN LENGTH AND THE NEW DEVICE WAS SHORTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865232 ↗

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