Shiley 6.5PELF (UDI 20884521779904)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521779904), received between Nov 10, 2021 and Dec 12, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S OBTURATOR WAS HARD AND DIFFICULT TO REMOVE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313894 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Device; Defective Component; Defective Device

  ACCORDING TO THE REPORTER, THE "OPTULATOR" OR THE STYLET OF THE TRACHEOSTOMY TUBE FITTED TOO TIGHTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302555 ↗
• MalfunctionAug 7, 2023Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE ANGLE OF THE TRACHEOSTOMY TUBE WAS TIGHT, AND THERE WAS RESISTANCE WHEN INSERTING AND REMOVING THE OBTURATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477163 ↗
• MalfunctionOct 31, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, WHEN CHECKING THE TRACHEOSTOMY TUBE PRIOR TO THE PLANNED TUBE REPLACEMENT, THE INTRODUCER WAS VERY DIFFICULT TO REMOVE. TRIED A SECOND TUBE FROM THE SAME LOT NUMBER, BUT IT WAS ALSO DIFFICULT TO MOVE. HOWEVER, ABLE TO MANAGE TO SAFELY AND SUCCESSFULLY PERFORM THE TUBE CHANGE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705123 ↗
• MalfunctionAug 5, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS SIGNIFICANT DIFFICULTY IN REMOVING THE "INTRODUCER" FROM THE TUBE PRIOR TO THE TUBE CHANGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15180177 ↗
• MalfunctionJul 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A SIGNIFICANT DIFFICULTY IN REMOVING THE "INTRODUCER" FROM THE TUBE PRIOR TO THE TUBE CHANGE.

  Patient problems: Insufficient Information

  MAUDE report 15117327 ↗
• MalfunctionJul 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A SIGNIFICANT DIFFICULTY IN REMOVING THE ""INTRODUCER"" FROM THE TUBE PRIOR TO THE TUBE CHANGE.

  Patient problems: Insufficient Information

  MAUDE report 15113074 ↗
• MalfunctionJul 27, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A SIGNIFICANT DIFFICULTIES IN REMOVING THE INTRODUCER FROM THE TUBE PRIOR TO THE TUBE CHANGE.

  Patient problems: Insufficient Information

  MAUDE report 15112621 ↗
• InjuryNov 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S FLANGE EYELET HAD A BREAKAGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 12786920 ↗

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.