Shiley 5.0 PDLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884522030021), received between Jun 27, 2021 and Apr 1, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE TUBE BROKE DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 13978198 ↗
• MalfunctionNov 12, 2021Material Separation; Material Separation

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD 3 DAMAGED TRACHES THAT WERE NOTED TO BE BREAKING AROUND THE LARYNX. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12802763 ↗
• MalfunctionOct 31, 2021Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FLANGE OF THE DEVICE HAD DAMAGED AND FELL OUT OF THE PATIENT. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 12725591 ↗
• MalfunctionOct 31, 2021Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE FLANGE OF THE DEVICE HAD DAMAGED AND FELL OUT OF THE PATIENT. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 12725589 ↗
• MalfunctionJul 25, 2021Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DAMAGE TRACH. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 12223057 ↗
• MalfunctionJun 29, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DAMAGED TUBE AROUND THE LARYNX OF THE PATIENT. IT WAS REPORTED, THAT THE TUBE WAS NOTED TO BE CRACKED. THE PATIENT WAS RECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 12084410 ↗
• MalfunctionJun 29, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DAMAGED TUBE AROUND THE LARYNX OF THE PATIENT. IT WAS REPORTED THAT THE TUBE WAS NOTED TO BE CRACKED. THE PATIENT WAS RECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 12084393 ↗
• MalfunctionJun 29, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DAMAGED TUBE AROUND THE LARYNX OF THE PATIENT. IT WAS REPORTED, THAT THE TUBE WAS NOTED TO BE CRACKED. THE PATIENT WAS RECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 12084353 ↗
• MalfunctionJun 27, 2021Use of Device Problem; Component Missing; Use of Device Problem; Component Missing

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO INNER CANNULA AND THE AREA AROUND THE FLANGE WAS BROKEN RIGHT WHERE IT TOGGLES THROUGH THE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073150 ↗

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