Shiley 4.0PEF (UDI 20884521779775)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20884521779775), received between Jul 12, 2022 and Jul 29, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 29, 2026Physical Resistance/Sticking

  It was reported that during pre-usage inspection, the introducer (obturator) was noted to be stiff and difficult to remove and insert thru the trach tube. Decision was made not to complete tube change as not confident that the introducer would be able to be removed in a timely manner which would risk blocking off of the tube and airway problems. Tube change aborted leading to delay in treatment. There was no patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50073802 ↗
• MalfunctionApr 7, 2026Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE STANDARD SPECIFICATIONS AND OTHER MARKINGS THAT SHOULD NORMALLY BE PRINTED ON THE NECK FLANGE WERE MISSING. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND PRINT DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811196 ↗
• MalfunctionApr 22, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT DURING USE, THERE WAS A BLUE LIKE DYE DISCOLORATION ON THE TRACH AFTER 10 DAYS OF PATIENT USE AS SHOWN IN THE IMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882623 ↗
• MalfunctionApr 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHED OBTURATOR DID NOT FIT INTO THE TUBE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869764 ↗
• MalfunctionDec 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO TRACHEOSTOMY TUBES WERE DEFECTIVE. THE ISSUE WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905947 ↗
• MalfunctionDec 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO TRACHEOSTOMY TUBES WERE DEFECTIVE. THE ISSUE WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905930 ↗
• MalfunctionNov 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE WAS FOUND DAMAGED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20641887 ↗
• MalfunctionOct 4, 2024Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBES WERE FOUND BROKEN IN THE SAME SPOT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372696 ↗
• MalfunctionSep 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD TEAR AND CUT FROM THE TUBE BASE AS SHOWN IN THE ATTACHED IMAGE. THE TUBE WAS REPLACED. ADDITIONAL INFORMATION RECEIVED, THE BROKEN CANNULA WAS PLACED AT THE END OF (B)(6) 2024. IT WAS ROTATED WITH SEVERAL CANNULAS, AND THE USAGE TIME MUST BE LESS THAN 2 MONTHS AND CAREFULLY FOLLOWED THE MAINTENANCE INSTRUCTIONS.

  Patient problems: Unintended Extubation

  MAUDE report 20236645 ↗
• MalfunctionAug 23, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S TIP WAS FOUND TO BE BENT. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20053899 ↗
• InjuryFeb 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, WHEN THE SIZE 4 TRACHEOSTOMY TUBE WAS PLACED, THE PATIENT STARTED COUGHING, AND THE DEVICE WAS DISCONTINUED AND REPLACED WITH A SIZE 3.5. AFTER THE SIZE 4 WAS REMOVED, IT WAS COMPARED WITH ANOTHER DEVICE OF THE SAME SIZE, AND IT WAS FOUND THAT THE ANGLE WAS DIFFERENT.

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

  MAUDE report 18738205 ↗
• MalfunctionAug 25, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A DAY AFTER THE TRACHEOSTOMY TUBE WAS REPLACED FROM THE PATIENT IT WAS NOTICED THAT IT WAS FLOATING, IT WAS CONFIRMED THAT THE CIRCULAR RING ON THE TRACH'S NECK FLANGE WAS DAMAGED. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17626128 ↗
• InjuryJun 30, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, WHEN THE TRACHEOSTOMY CANNULA WAS INSERTED INTO THE CHILD'S BODY, IT WAS FOUND THAT THE TRACHEOSTOMY CANNULA HUB BECAME COMPLETELY SEPARATED FROM THE TUBE, IMMEDIATELY REPORTED TO THE DIRECTOR OF THE DEPARTMENT AND INVITE EXPERTS FROM RELEVANT DEPARTMENTS OF OUR HOSPITAL TO CONSULT. THE MEDICAL STAFF TOOK EFFECTIVE MEASURES TO REMOVE THE TRACHEOTOMY CANNULA SMOOTHLY AND QUICKLY. IMMEDIATELY REPLACED IT WITH OTHER TRACHEOSTOMY CANNULA TO CONTINUE TREATING THE CHILD AND COMPLETING THE TREATMENT PROCEDURE.

  Patient problems: Foreign Body In Patient; Unintended Extubation

  MAUDE report 17243057 ↗
• MalfunctionApr 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE PRODUCT WAS CHECKED VISUALLY PRIOR TO USE, IT WAS FOUND THAT THE INTRODUCER WAS DIFFICULT TO PASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705063 ↗
• MalfunctionApr 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE PRODUCT WAS CHECKED VISUALLY PRIOR TO USE, IT WAS FOUND THAT THE INTRODUCER WAS DIFFICULT TO PASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705062 ↗
• MalfunctionApr 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE PRODUCT WAS CHECKED VISUALLY PRIOR TO USE, IT WAS FOUND THAT THE INTRODUCER WAS DIFFICULT TO PASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705057 ↗
• MalfunctionApr 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE PRODUCT WAS CHECKED VISUALLY PRIOR TO USE, IT WAS FOUND THAT THE INTRODUCER WAS DIFFICULT TO PASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705056 ↗
• MalfunctionJan 16, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USAGE OF THE NEW TRACH MODEL, CUSTOMER HAD A COMPLAINT ABOUT THE MOLD BEING NARROWER INSIDE THAT THE OBTURATOR WAS NOT SLIDING IN NICELY IN WHICH THE SUCTIONING NEVER QUITE CLEANS THE INNER CANNULA. IT WAS ALSO CAUSING THE PATIENT UNABLE TO COUGH THE SECRETION OUT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173751 ↗
• MalfunctionSep 7, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PARENT OF THE CHILD SAID THAT THE PATIENT CONTINUES TO DECANNULATE HIMSELF EVERY TIME THE PATIENT TRIED TO REMOVE THE HME. THE PATIENT WAS USING HME WITH THE TRACH WHEN STARTED TO USE THE PEF. THE PARENT ALSO ADDED THAT THE PATIENT HAS DEVELOPMENTAL DELAY. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372212 ↗
• MalfunctionAug 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE OBTURATOR WAS DIFFICULT TO REMOVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279054 ↗
• MalfunctionJul 22, 2022Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE OBTURATOR WAS DIFFICULT TO REMOVE. WHEN THE COTTON TWILL TIES WERE BEING PUT THROUGH THE FLANGE TO SECURE THE TUBE IN POSITION, THE REPROCESSED TUBE HAD ALREADY BEEN INSERTED. IT WAS NOT NOTICED PRIOR TO INSERTION AND THE NEW TUBE WAS REINSERTED WHEN THE FLANGE FOUND TO HAVE A SPLIT. IT WAS NOTED THAT THE DEVICE WAS CHECKED PRIOR TO USE. THE PATIENT WAS UNHARMED AS IT WAS NOTICED WHEN TRYING TO SECURE THE TUBE IN POSITION.

  Patient problems: Unintended Extubation

  MAUDE report 15088075 ↗
• MalfunctionJul 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, REMOVAL OF THE OBTURATOR PRIOR TO USE WAS DIFFICULT SO IT WAS DEEMED FAULTY AND A RISK TO USE. IT WAS NOTED THAT THE PRODUCT WAS VISUALLY CHECKED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087917 ↗
• MalfunctionJul 12, 2022Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE PRODUCT WAS CHECK VISUALLY PRIOR TO USE, IT WAS FOUND THAT THE INTRODUCER WAS DIFFICULT TO PASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991931 ↗

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.