Shiley 4.5 NEORecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30884522026684), received between Jul 24, 2017 and Jul 19, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD RUPTURE OF CANNULA FIXATION ON THE RIGHT WING. THE CANNULA WAS CHANGED WITHOUT COMPLICATIONS.

  Patient problems: Extubate

  MAUDE report 8809680 ↗
• InjuryJun 19, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, A FRENCH 8 SUCTION CATHETER WAS STUCK IN THE CANNULA AND WAS INSERTED FORCIBLY BUT AN ABNORMAL SOUND LIKE RUBBING IN THE CANNULA LUMEN WAS HEARD. THE SUCTION CATHETER WAS USED ONCE. THEREAFTER, THE CATHETER WAS UNABLE TO BE INSERTED AT ALL. A NARROWING OF THE TRACHEOSTOMY TUBE WAS SUSPECTED. REPLACEMENT OF THE CANNULA WAS PERFORMED.

  Patient problems: Extubate

  MAUDE report 8712800 ↗
• InjuryMay 10, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD BROKEN CANNULA. IT WAS REPORTED THAT WHEN ASPIRATING TRACHEAL SECRETIONS BY TRACHEOTOMY TUBE (CANNULA TPT). TENS NOTICES THAT THE TUBE IS MOVING, BROKEN CANNULA. NURSE EVALUATES AND CONFIRMS THE SITUATION, A DOCTOR IS NOTIFIED OF THE SHIFT. TPT CHANGE WAS MADE. THEY WERE DISCARDED BY CUSTOMER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Extubate

  MAUDE report 8601471 ↗
• MalfunctionJul 24, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, DIRT WAS FOUND ADHERED TO SEVERAL SPOTS OF THE TRACHEAL TUBE UPON OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6735188 ↗

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