Shiley 6.5PELF (UDI 10884521103436)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521103436), received between Apr 13, 2023 and Jun 16, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• MalfunctionJun 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD SKIN REDNESS AND SWELLING AFTER USING THE PELF TRACH CANNULA. THE TRACH CANNULA WAS TRIED SEVERAL TIMES, BUT THE ISSUE STILL PERSISTS. THE PATIENT RETURNED TO USING THE OLD PDL TRACH CANNULA.

  Patient problems: Discomfort; Inflammation; Skin Inflammation/ Irritation; Swelling/ Edema; Unintended Extubation

  MAUDE report 17148326 ↗
• InjuryJun 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD SKIN REDNESS AND SWELLING AFTER USING THE PELF TRACH CANNULA. THE TRACH CANNULA WAS TRIED SEVERAL TIMES, BUT THE ISSUE STILL PERSISTED. THE PATIENT RETURNED TO USING THE OLD PDL TRACH CANNULA.

  Patient problems: Discomfort; Inflammation; Skin Inflammation/ Irritation; Swelling/ Edema; Unintended Extubation

  MAUDE report 17134292 ↗
• InjuryApr 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN ALLERGIC REACTION TO SILICONE WITH A NEWLY PLACED TRACH DESPITE USING THE SAME CUSTOM TRACH MADE OF POLYVINYL CHLORIDE (PVC) FOR A LONG TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 16731612 ↗

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.