Shiley 6CFSRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 60884522006960), received between Apr 25, 2018 and Oct 17, 2023 — classified as 2 deaths, 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA HAD A LEAK EVERY TIME THE PATIENT COUGHED AFTER 20 DAYS OF USE. DURING REPLACEMENT, ONE OF THE LOCKING PINS (PRESENT ON THE FLANGE) WAS FOUND BROKEN, WHICH CAUSED THE CONTINUOUS CANNULA DISLOCATION.

  Patient problems: Unintended Extubation

  MAUDE report 17953794 ↗
• MalfunctionNov 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A SCRATCH ON THE INNER CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859809 ↗
• MalfunctionNov 15, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WAS NOT EASILY ENGAGEABLE WITH THE TRACHEOSTOMY TUBE AND UNABLE TO SECURED CORRECTLY. IT WAS EXCEPTIONALLY DIFFICULT TO TURN THE RE-USABLE INNER CANNULA INTO THE LOCKING POSITION AND TOOK MULTIPLE PEOPLE TO GET IT TO TURN AND LOCK IN PLACE. AN INNER CANNULA FROM ANOTHER BOX WAS USED TO CHANGE IT.

  Patient problems: Unintended Extubation

  MAUDE report 12817741 ↗
• MalfunctionNov 15, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WAS NOT EASILY ENGAGEABLE WITH THE TRACHEOSTOMY TUBE AND UNABLE TO SECURE CORRECTLY. IT WAS EXCEPTIONALLY DIFFICULT TO TURN THE RE-USABLE INNER CANNULA INTO THE LOCKING POSITION AND TOOK MULTIPLE PEOPLE TO GET IT TO TURN AND LOCK IN PLACE. AN INNER CANNULA FROM ANOTHER BOX WAS USED TO CHANGE IT.

  Patient problems: Unintended Extubation

  MAUDE report 12811646 ↗
• MalfunctionOct 22, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WAS NOT EASILY ENGAGEABLE WITH THE TRACHEOSTOMY TUBE AND UNABLE TO SECURED CORRECTLY. IT WAS EXCEPTIONALLY DIFFICULT TO TURN THE RE-USABLE INNER CANNULA INTO THE LOCKING POSITION AND TOOK MULTIPLE PEOPLE TO GET IT TO TURN AND LOCK IN PLACE. AN INNER CANNULA FROM ANOTHER BOX WAS USED TO CHANGE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682545 ↗
• MalfunctionOct 21, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE INNER CANNULA WAS NOT EASILY ENGAGEABLE WITH THE TRACHEOSTOMY TUBE AND UNABLE TO SECURED CORRECTLY. IT WAS EXCEPTIONALLY DIFFICULT TO TURN THE RE-USABLE INNER CANNULA INTO THE LOCKING POSITION AND TOOK MULTIPLE PEOPLE TO GET IT TO TURN AND LOCK IN PLACE. AN INNER CANNULA FROM ANOTHER BOX WAS USED TO CHANGE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12670166 ↗
• MalfunctionOct 21, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO BE SECURED CORRECTLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12670162 ↗
• MalfunctionJul 20, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A DOWN-SIZE TRACH WAS PERFORMED FROM THE UNIT WITH A SIZE 8 TO A 6. WHEN THE TRACH WAS CHECK, IT WAS FOUND THAT THE LOCKING OF THE INNER CANNULA WAS VERY DIFFICULT AS IT WAS EXTREMELY TIGHT. ONCE ABLE TO DO IT, SO PROCEEDED WITH THE CHANGE. WHEN THE TUBE WAS IN SITU, IT COMPLETELY UNABLE TO LOCK IN THE INNER CANNULA. IT WAS SO TIGHT THAT IT SIMPLY WOULD NOT TURN/LOCK AND ENDED UP CALLING FOR A SECOND TUBE. THE SECOND TUBE WAS CHECK, AGAIN IT WAS UNABLE TO LOCK THE INNER CANNULA, AND EVEN TRIED THE LOW PROFILE AND RED-TIPPED PLUG CANNULA THAT CAME IN THE BOX, THE SAME ISSUE OCCURRED. A PIECE OF THE LOCKING POINT ON THE INNER CANNULA WAS WHITTLED. THE PATIENT HAD SINCE BEEN DE-CANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 12200158 ↗
• MalfunctionJul 20, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A DOWN-SIZE TRACH WAS PERFORMED FROM THE UNIT WITH A SIZE 8 TO A 6. WHEN THE TRACH WAS CHECK, IT WAS FOUND THAT THE LOCKING OF THE INNER CANNULA WAS VERY DIFFICULT AS IT WAS EXTREMELY TIGHT. ONCE ABLE TO DO IT, SO PROCEEDED WITH THE CHANGE. WHEN THE TUBE WAS IN SITU, IT COMPLETELY UNABLE TO LOCK IN THE INNER CANNULA. IT WAS SO TIGHT THAT IT SIMPLY WOULD NOT TURN/LOCK AND ENDED UP CALLING FOR A SECOND TUBE. THE SECOND TUBE WAS CHECK, AGAIN IT WAS UNABLE TO LOCK THE INNER CANNULA, AND EVEN TRIED THE LOW PROFILE AND RED-TIPPED PLUG CANNULA THAT CAME IN THE BOX, THE SAME ISSUE OCCURRED. A PIECE OF THE LOCKING POINT ON THE INNER CANNULA WAS WHITTLED. THE PATIENT HAD SINCE BEEN DE-CANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 12200146 ↗
• MalfunctionJul 14, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WOULD NOT TWIST AND LOCK WHEN CHANGING TUBE ON PATIENT IN ENT OUTPATIENTS. THERE WAS NO PATIENT INJURY/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164554 ↗
• MalfunctionMay 10, 2021Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE DEVICE'S WHOLE CAP PART AND INNER CANNULA BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798392 ↗
• MalfunctionApr 26, 2021Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE WHOLE CAP PART OF THE TRACH AND INNER CANNULA BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727615 ↗
• MalfunctionApr 15, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS A PROBLEM WITH LOCKING THE COUNTER-CANNULA. DURING THE CANNULA CHANGE PHASE, THE COUNTER-CANNULA ALREADY INSERTED IN THE CANNULA WAS NOT CHECKED AT THE FIRST CLEANING OPERATION. IT WAS NOT POSSIBLE TO EXTRACT THE COUNTER CANNULA AS IT WAS BLOCKED. THE ENTIRE CANNULA HAD TO BE REPLACED. THE ISSUE OCCURRED AT THE PATIENT'S HOME. THE PATIENT WENT TO THE EMERGENCY ROOM. EVEN AFTER REMOVING THE CANNULA FROM THE PATIENT, THE NURSES WERE UNABLE TO DISASSEMBLE THE COUNTER-CANNULA.

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

  MAUDE report 11671044 ↗
• MalfunctionNov 13, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S SIZE 6 INNER CANNULA PROTRUDED OUTSIDE THE OUTER CANNULA, CAUSING THE INNER CANNULA TO RUB ALONG PATIENT'S TRACHEA. THERE WAS REPORTED PATIENT INVOLVEMENT BUT UNKNOWN OUTCOME.

  Patient problems: No Information

  MAUDE report 10834263 ↗
• InjuryMar 31, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE INNER CANNULA WAS TIGHT AD DIFFICULT TO LOCK AND UNLOCK TO OUTER CANNULA. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 9908823 ↗
• MalfunctionMar 9, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD LOCK AND UNLOCK ISSUE BETWEEN THE MAJOR INNER TUBE AND THE OUTER TUBE. IT NEEDED EXTREME FORCE TO UNLOCK AND LOCK THE MAJOR INNER TUBE AND TRIED TO USE ANOTHER TWO NEW MAJOR INNER TUBES TO DO THE SAME PROCESS AGAIN BUT WERE ALSO DIFFICULT TO DO SO. IT REACHED A DANGEROUS FORCE LEVEL TO GET LOCKING AND UNLOCKING DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805084 ↗
• MalfunctionFeb 18, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S INNER CANNULA WOULD NOT FIT TO THE CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9719966 ↗
• MalfunctionFeb 18, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S INNER CANNULA WOULD NOT FIT TO THE CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9719874 ↗
• InjuryFeb 4, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT'S INNER CANNULA WAS BROKEN AND LOCKED ON THE FLANGE'S SIDE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate; No Information

  MAUDE report 9666469 ↗
• MalfunctionJan 23, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE'S INNER CANNULA HAD A DIMENSIONAL ISSUE. IT WAS REPORTED THAT THEY HAD DIFFICULTY INSERTING AND TAKING OUT THE INNER CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9621477 ↗
• MalfunctionDec 26, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD EXTREME DIFFICULTY IN LOCKING AND UNLOCKING THE INNER CANNULA OF TRACHEOSTOMY TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9521881 ↗
• MalfunctionDec 26, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS EXTREME DIFFICULTY IN LOCKING AND UNLOCKING THE INNER CANNULA OF THE TRACHEOSTOMY TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9520046 ↗
• DeathDec 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, A TRACHEOSTOMY WAS PERFORMED TO IMPROVE BREATHING AS THE VOCAL CORDS WERE PARTIALLY FROZEN, BLOCKING THE AIRWAY. DURING USE, THE DEVICE RUPTURED THE PATIENT¿S CEPHALIC ARTERY. ADDITIONAL INFORMATION RECEIVED NOTES THAT THE PATIENT PASSED AWAY. THE PATIENT HAS A HISTORY OF COPD AND RIGHT SIDED LUNG CANCER. THE PATIENT HAD CONCOMITANT MEDICAL TREATMENTS OF KEYTRUDA IMMUNOTHERAPY, ALBUTEROL IN VAPORIZER, MORPHENE 5ML/DAY, AND MULTIVITAMINS.

  Patient problems: Cancer; Chronic Obstructive Pulmonary Disease (COPD); Death; Fistula; Hemorrhage/Blood Loss/Bleeding; Injury; Pneumothorax; Unspecified Tissue Injury

  MAUDE report 9476011 ↗
• MalfunctionDec 12, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT HAD 3 TRACKS AND THE INNER TRACK WAS TOO LONG, THESE WERE LEFT TO THE PATIENT FOR 3 MONTHS DUE TO WELFARE CONSTRAINTS. THE CUSTOMERS STATED THE PATIENT ATTEMPTED TO CUT THEM DOWN. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Information

  MAUDE report 9463041 ↗
• MalfunctionDec 12, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT HAD 3 TRACKS AND THE INNER TRACK WAS TOO LONG, THESE WERE LEFT TO THE PATIENT FOR 3 MONTHS DUE TO WELFARE CONSTRAINTS. THE CUSTOMERS STATED THE PATIENT ATTEMPTED TO CUT THEM DOWN. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Information

  MAUDE report 9462914 ↗

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-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-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-1470-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1479-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• 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-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-1471-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• 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-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-1491-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Inten
• 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-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-1477-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• Z-1462-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f

…and 8 more.