Shiley 6.0PELF (UDI 20884521779898)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20884521779898), received between Mar 8, 2022 and Sep 22, 2026 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Obstruction of Flow

  Patient problems: Insufficient Information

  MAUDE report 50860649 ↗
• InjurySep 22, 2026Obstruction of Flow

  Patient problems: Insufficient Information

  MAUDE report 50860588 ↗
• InjurySep 22, 2026Obstruction of Flow

  Patient problems: Insufficient Information

  MAUDE report 50860542 ↗
• InjurySep 22, 2026Obstruction of Flow

  Patient problems: Insufficient Information

  MAUDE report 50860499 ↗
• InjurySep 18, 2026Material Discolored; Obstruction of Flow

  It was reported that tracheostomy tubes were associated with stoma irritation and did not last as expected, requiring replacement ap proximately every 2 weeks rather than the usual 4 weeks. Yellow discoloration was observed at the top of the tracheostomy. Secretions formed a barrier inside the tracheostomy and were not completely removed by suctioning. The patient experienced decreased oxygen levels, increased carbon dioxide levels, and near loss of consciousness.

  Patient problems: Hypoxia; Low Oxygen Saturation; Presyncope; Skin Inflammation/ Irritation

  MAUDE report 50820072 ↗
• InjurySep 16, 2026Obstruction of Flow

  It was reported that tracheostomy tubes were associated with stoma irritation and did not last as expected, requiring replacement ap proximately every 2 weeks rather than the usual 4 weeks. Yellow discoloration was observed at the top of the tracheostomy. Secretions formed a barrier inside the tracheostomy and were not completely removed by suctioning. The patient experienced decreased oxygen levels, increased carbon dioxide levels, and near loss of consciousness.

  Patient problems: Insufficient Information

  MAUDE report 50783445 ↗
• MalfunctionJun 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A 6.0 MM THE TRACHEOSTOMY TUBE'S CANNULA WAS BROKEN AT THE BASE OF THE FLANGE IN A HOME CARE SETTING. THE PATIENT EXPERIENCED SIGNIFICANT DISCOMFORT BUT WITH NO INJURY.

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

  MAUDE report 22232733 ↗
• MalfunctionOct 14, 2024Material Discolored; Material Separation; Material Discolored; Material Separation

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CANNULA WAS BROKEN AT THE BASE OF THE FLANGE FROM THE SECOND TIME. THE CANNULA WAS ALSO MENTIONED DISCOLORED RED BECAUSE THE CHILD HAS FREQUENT ASPIRATION EPISODES. THE TUBE WAS REPLACED. ADDITIONAL INFORMATION RECEIVED: NO THE ASPIRATION IS INHERENT TO HER CONDITION. HOWEVER, CUSTOMER SAYS PATIENT IMMEDIATELY EXPRESSED SIGNIFICANT DISCOMFORT EACH TIME THE CANNULA BROKE.

  Patient problems: Unintended Extubation

  MAUDE report 20445937 ↗
• MalfunctionSep 7, 2023Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS CHANGED AFTER ONE MONTH OF USED AND IT WAS MOLDY LOOKING BASED ON THE PHOTO PROVIDED. THE TRACH WAS CHANGE AS IT WAS DUE TO BE CHANGED AND THE PATIENT WAS FELT ALL GOOD AND SHOWED NO SIGNS OF SICKNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17700786 ↗
• MalfunctionSep 7, 2023Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS CHECKED AFTER A WEEK OF USED AND IT WAS MOLDY LOOKING. A SAMPLE OF THE PATIENT'S SECRETION WAS TAKEN AND THERE WAS NO FUNGAL GROWTH OR INFECTION FOUND. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17700293 ↗
• MalfunctionNov 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE INTRODUCER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846862 ↗
• MalfunctionNov 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE INTRODUCER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845758 ↗
• MalfunctionNov 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE INTRODUCER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845741 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE OBTURATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837246 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE OBTURATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15836467 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE OBTURATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15836234 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE OBTURATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835540 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE OBTURATOR.. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835498 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE OBTURATOR.. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835453 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY ON INSERTING AND REMOVING THE DEVICE OBTURATOR.. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835382 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY INSERTING AND REMOVING THE DEVICE OBTURATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833949 ↗
• MalfunctionMar 29, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT STATED COULD NOT BREATHE AND DID NOT FEEL RIGHT WHEN THE DEVICE WAS USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945741 ↗
• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE LATERAL FLANGE OF THE DEVICE WAS BROKEN THAT AVOIDS PROPER FIXATION OF THE CANNULA. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 13699832 ↗

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.