Shiley 6.0PELF (UDI 10884521101630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521101630), received between Apr 18, 2022 and Mar 8, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K122531, K182861); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA WAS CUT IN 2 AT THE BASE DURING USE. THE PATIENT WAS DECANNULATED AND THE CANNULA WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18868314 ↗
• InjuryApr 18, 2022Disconnection; Patient-Device Incompatibility; Material Split, Cut or Torn; Disconnection; Patient-Device Incompatibility; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S FLAT BROKE. THE PATIENT HAD DESATURATION, SPO2 AND HEART RATE INCREASED.

  Patient problems: Low Oxygen Saturation; Tachycardia; Unintended Extubation

  MAUDE report 14137277 ↗
• InjuryApr 18, 2022Disconnection; Patient-Device Incompatibility; Material Split, Cut or Torn; Disconnection; Patient-Device Incompatibility; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S FLAT BROKE. THE PATIENT HAD DESATURATION, OXYGEN SATURATION (SPO2) AND HEART RATE INCREASED.

  Patient problems: Low Oxygen Saturation; Tachycardia; Unintended Extubation

  MAUDE report 14137105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122531, K182861. One submission often covers many models, so check the product and lot details in each record.

• Z-1951-2015 · May 8, 2015 · Terminated
  Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.