Shiley 4CFSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 60884522006953), received between Aug 27, 2018 and Nov 30, 2021 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A VALVE GOT STUCK ON THE DEVICE AND TOOK OVER 30 MINUTES TO GET THE VALVE OFF THE INNER CANNULA. THE PATIENT HAD A REPLACEMENT OF THE CANNULA.

  Patient problems: Unintended Extubation

  MAUDE report 12898527 ↗
• InjuryApr 3, 2020Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA DOES NOT SECURE TO THE OUTER CANNULA. DESPITE THE FACT THAT THEY WERE ABLE TO LINE UP THE CIRCLES OF THE OUTER AND INNER CANNULA , THE INNER CANNULA WOULD NOT STAY IN PLACE. THEY HAVE PROBLEMS INSERTING THE TRACK AND INNER CANNULA DOES NOT CLICK AND FITS INSIDE AND IF THE PATIENT COUGH IT GETS OUT. DECANNULATION AND RE-INSERTION OF A NEW TRACH WAS REQUIRED

  Patient problems: Extubate

  MAUDE report 9919778 ↗
• MalfunctionDec 18, 2019Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem

  ACCORDING TO THE REPORTER, WHEN THEY PERFORMED TRACHEOSTOMY TUBE (OUTER AND INNER CANNULA) THEY WERE UNABLE TO GET THE INNER CANNULA TO SECURE TO THE OUTER CANNULA. THE CUSTOMER ALSO STATED THAT DESPITE THE FACT THAT THEY WERE ABLE TO LINE UP THE CIRCLES OF THE OUTER AND INNER CANNULA, THE INNER CANNULA WOULD NOT STAY IN PLACE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9488372 ↗
• InjurySep 18, 2019Crack; Crack

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A TRACH CANNULA CHANGE ON (B)(6) "1919", THE CANNULA CONNECTOR PRESENTED CRACKING. IT WAS NECESSARY TO CHANGE THE DEVICE AS SOON AS POSSIBLE, BEFORE THE COMPLETE RUPTURE OF THE CANNULA OCCURS. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 9083746 ↗
• InjuryApr 19, 2019Break; Break

  ACCORDING TO THE REPORTER, THE UNIT HAD HOLE IN THE FLANGE AND A BROKEN TRACHEOSTOMY TIE. THE PATIENT HAD TO BE RECANNULATED.

  Patient problems: Extubate

  MAUDE report 8531658 ↗
• InjuryApr 19, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, ONE PATIENT HAD 3 CONSECUTIVE TRACHS FAILED WHERE THE HOLE IN THE FLANGE FOR THE TRACH TIE BROKE. THE PATIENT HAD TO BE RECANNULATED DUE TO THE ISSUE.

  Patient problems: Extubate

  MAUDE report 8530228 ↗
• InjuryApr 18, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, ONE PATIENT HAD 3 CONSECUTIVE TRACHS FAILED WHERE THE HOLE IN THE FLANGE FOR THE TRACH TIE BROKE. THE PATIENT HAD TO BE RECANNULATED DUE TO THE ISSUE.

  Patient problems: Extubate

  MAUDE report 8530217 ↗
• MalfunctionNov 30, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA WITH NUMBER 3 ON IT DID NOT FIT IN THE TRACHEOSTOMY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8120007 ↗
• MalfunctionNov 15, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THERE WAS A SEPARATION OF THE CUFF FROM THE REST OF THE CANNULA. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074782 ↗
• MalfunctionSep 21, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE PATIENT HAD THE CORPS OF THE CANNULA IN HIS HANDS AND THE COLLAR STAYED ON HIS NECK. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898884 ↗
• MalfunctionAug 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE DEVICE'S OUTER CANNULA HAD A 4 ON IT BUT THE OUTER CANNULA HAS 3 ON IT. IT WAS INDICATED THAT SOME OF THE INNER CANNULA FIT TIGHTER, DIFFICULT TO REMOVE AND BREATHE THROUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818556 ↗

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-1476-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• 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-1481-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• 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-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-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-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
• 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-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-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-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-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-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-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

…and 8 more.