Shiley 4CFNRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 50884522006918), received between Sep 30, 2019 and Sep 5, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 reports).

23 other recalls cover devices cleared under the same FDA submission (K962173); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TRACHEAL CANNULA EXPERIENCED PHYSICAL DAMAGE WHEN A FLEX TUBE CONNECTOR BECAME STUCK ON THE 15 MILLIMETER CONNECTOR OF THE CANNULA DURING USE AT A CARE FACILITY. THE CANNULA, WHICH HAD BEEN IN USE FOR FOUR DAYS, HAD TO BE REMOVED FROM THE TRACHEA, AND DURING ATTEMPTS TO DETACH THE FLEX TUBE CONNECTOR, THE CANNULA BROKE. A NEW CANNULA WAS INSERTED.

  Patient problems: Unintended Extubation

  MAUDE report 22980481 ↗
• MalfunctionAug 19, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING USE; THE TRACH TUBE'S GREEN STOPPER WAS FOUND MISSING FROM THE BOX. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22843205 ↗
• InjuryMay 5, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE LENGTH OF THE TRACH HAS BEEN INCONSISTENT WITH SOME WERE VERY SHORT AND LONG. THE INNER CANNULAS WERE OFTEN JAGGED AT THE EDGE AND APPEARED NOT TO BE PROPERLY CUT. OFTEN THE INNER CANNULAS WOULD STICK OUT PAST THE OUTER TRACH SHAFT. SOME TRACHS HAD TINY THREADS OR SHAVINGS OF PLASTIC STICKING OUT FROM THE OUTER EDGE OF THE OUTER TRACH SHAFT. THE TRACHS DID NOT SEEM TO FIT RIGHT AND WAS CAUSING A GREAT DEAL OF PAIN AND DISCOMFORT TO PATIENT'S AIRWAY AND AROUND THE STOMA. THE PATIENT HAD DIFFICULTY WITH BREATHING OFF AND ON WHEN THE PAIN GOT WORSE. THE TRACH WAS CHANGED FREQUENTLY FOR RELIEF FROM GREAT IRRITATION ON THE PATIENT'S CHEST.

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

  MAUDE report 16882567 ↗
• InjuryMay 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE LENGTH OF THE TRACH HAS BEEN INCONSISTENT WITH SOME WERE VERY SHORT AND LONG. THE INNER CANNULAS WERE OFTEN JAGGED AT THE EDGE AND APPEARED NOT TO BE PROPERLY CUT. OFTEN THE INNER CANNULAS WOULD STICK OUT PAST THE OUTER TRACH SHAFT. SOME TRACHS HAD TINY THREADS OR SHAVINGS OF PLASTIC STICKING OUT FROM THE OUTER EDGE OF THE OUTER TRACH SHAFT. THE TRACHS DID NOT SEEM TO FIT RIGHT AND WAS CAUSING A GREAT DEAL OF PAIN AND DISCOMFORT TO PATIENT'S AIRWAY AND AROUND THE STOMA. THE PATIENT HAD DIFFICULTY WITH BREATHING OFF AND ON WHEN THE PAIN GOT WORSE. THE TRACH WAS CHANGED FREQUENTLY FOR RELIEF FROM GREAT IRRITATION ON THE PATIENT'S CHEST.

  Patient problems: Discomfort; Pain; Unintended Extubation

  MAUDE report 16876377 ↗
• InjuryMay 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE LENGTH OF THE TRACH HAS BEEN INCONSISTENT WITH SOME WERE VERY SHORT AND LONG. THE INNER CANNULAS WERE OFTEN JAGGED AT THE EDGE AND APPEARED NOT TO BE PROPERLY CUT. OFTEN THE INNER CANNULAS WOULD STICK OUT PAST THE OUTER TRACH SHAFT. SOME TRACHS HAD TINY THREADS OR SHAVINGS OF PLASTIC STICKING OUT FROM THE OUTER EDGE OF THE OUTER TRACH SHAFT. THE TRACHS DID NOT SEEM TO FIT RIGHT AND WAS CAUSING A GREAT DEAL OF PAIN AND DISCOMFORT TO PATIENT'S AIRWAY AND AROUND THE STOMA. THE PATIENT HAD DIFFICULTY WITH BREATHING OFF AND ON WHEN THE PAIN GOT WORSE. THE TRACH WAS CHANGED FREQUENTLY FOR RELIEF FROM GREAT IRRITATION ON THE PATIENT'S CHEST.

  Patient problems: Discomfort; Pain; Unintended Extubation

  MAUDE report 16876350 ↗
• InjuryMay 5, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE LENGTH OF THE TRACH HAS BEEN INCONSISTENT WITH SOME WERE VERY SHORT AND LONG. THE INNER CANNULAS WERE OFTEN JAGGED AT THE EDGE AND APPEARED NOT TO BE PROPERLY CUT. OFTEN THE INNER CANNULAS WOULD STICK OUT PAST THE OUTER TRACH SHAFT. SOME TRACHS HAD TINY THREADS OR SHAVINGS OF PLASTIC STICKING OUT FROM THE OUTER EDGE OF THE OUTER TRACH SHAFT. THE TRACHS DID NOT SEEM TO FIT RIGHT AND WAS CAUSING A GREAT DEAL OF PAIN AND DISCOMFORT TO PATIENT'S AIRWAY AND AROUND THE STOMA. THE PATIENT HAD DIFFICULTY WITH BREATHING OFF AND ON WHEN THE PAIN GOT WORSE. THE TRACH WAS CHANGED FREQUENTLY FOR RELIEF FROM GREAT IRRITATION ON THE PATIENT'S CHEST.

  Patient problems: Discomfort; Pain; Unintended Extubation

  MAUDE report 16876324 ↗
• InjuryMay 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE LENGTH OF THE TRACH HAS BEEN INCONSISTENT WITH SOME WERE VERY SHORT AND LONG. THE INNER CANNULAS WERE OFTEN JAGGED AT THE EDGE AND APPEARED NOT TO BE PROPERLY CUT. OFTEN THE INNER CANNULAS WOULD STICK OUT PAST THE OUTER TRACH SHAFT. SOME TRACHS HAD TINY THREADS OR SHAVINGS OF PLASTIC STICKING OUT FROM THE OUTER EDGE OF THE OUTER TRACH SHAFT. THE TRACHS DID NOT SEEM TO FIT RIGHT AND WAS CAUSING A GREAT DEAL OF PAIN AND DISCOMFORT TO PATIENT'S AIRWAY AND AROUND THE STOMA. THE PATIENT HAD DIFFICULTY WITH BREATHING OFF AND ON WHEN THE PAIN GOT WORSE. THE TRACH WAS CHANGED FREQUENTLY FOR RELIEF FROM GREAT IRRITATION ON THE PATIENT'S CHEST.

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

  MAUDE report 16876293 ↗
• MalfunctionAug 13, 2020Installation-Related Problem; Installation-Related Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF AND TUBE DID NOT FIT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10401057 ↗
• MalfunctionJun 12, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF AND TUBE DID NOT FIT TOGETHER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148348 ↗
• MalfunctionSep 30, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE PATIENT REPORTED THAT THERE WAS A SMALL PLASTIC STICKING OUT OF THE TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Information

  MAUDE report 9135738 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962173. One submission often covers many models, so check the product and lot details in each record.

• Z-2174-2012 · Jul 18, 2012 · Terminated
  Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product
• Z-1472-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1473-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, C
• Z-1480-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1467-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1466-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1469-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for byp
• Z-1478-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1468-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1489-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1463-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1464-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1465-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended
• Z-1488-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1490-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend

…and 8 more.