Shiley 4.0 NEORecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30884522026677), received between Jun 26, 2017 and Jul 18, 2022 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• DeathJul 18, 2022Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE PATIENT WAS DECEASED WITH UNKNOWN CAUSE OF DEATH.

  Patient problems: Hypoxia; Insufficient Information; Unintended Extubation; Wheezing

  MAUDE report 15037024 ↗
• MalfunctionMar 7, 2021Material Separation; Material Separation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT WAS APPROXIMATELY 2MM SHORTER THAN SPECIFICATION. ANOTHER PRODUCT HAD A BENT CANNULA INTERNALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11427862 ↗
• MalfunctionJan 8, 2018Contamination; Contamination

  ACCORDING TO THE REPORTER DURING INSPECTION PRIOR TO USE ON A PATIENT, THE TUBE WAS FOUND DIRTY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7173324 ↗
• MalfunctionJun 26, 2017Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED A REPORT THAT THE NECK FLANGE HOLES WERE TORN. CUSTOMER INDICATED THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6668863 ↗
• MalfunctionJun 26, 2017Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED A REPORT THAT THE NECK FLANGE HOLES WERE TORN. CUSTOMER INDICATED THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6668860 ↗

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