Shiley 6CFNRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 40884522006928), received between Mar 15, 2017 and Sep 18, 2026 — classified as 11 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (22 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Use of Device Problem

  Patient problems: Pain

  MAUDE report 50831209 ↗
• MalfunctionJul 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063603 ↗
• InjuryApr 22, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING USE, THE PATIENT EXPERIENCED BLEEDING AND WAS SENT TO THE EMERGENCY ROOM BECAUSE IT WAS MENTIONED THAT THE INNER CANNULA WAS TOO LONG COMPARED TO OTHER LOTS OF THE SAME PRODUCT. THE TUBE WAS NOT REPLACED AND DECIDED NOT TO USE TRACH TUBE ANYMORE AND THE BLEEDING STOPPED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Extubation

  MAUDE report 24955565 ↗
• MalfunctionMar 19, 2026Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULA OF THE TRACHEOSTOMY TUBE WAS TOO TIGHT AND HARD TO TWIST OPEN AT A HOMECARE CENTER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644178 ↗
• MalfunctionMay 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULA COULD NOT LOCK TIGHTLY DURING USE AT A HOSPITAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039501 ↗
• MalfunctionMay 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULA COULD NOT LOCK TIGHTLY DURING USE AT A HOSPITAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039495 ↗
• MalfunctionMay 16, 2025Disconnection; Patient-Device Incompatibility; Disconnection; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE TRACH TUBE EXPERIENCED AN ISSUE AT THE HOSPITAL WHERE TWO CLIPS THAT HOLD THE INNER AND OUTER CANNULA SNAPPED. THE TRACH WAS NOTED TO BE LOOSE, AND UPON THE PATIENT COUGHING, THE INNER AND OUTER SECTIONS OF THE TRACH CAME OUT AND WERE FOUND ON THE PATIENT'S LAP. STAFF RESPONDED BY REINSERTING THE TRACH INTO THE STOMA SITE AND PERFORMED AN EMERGENCY TRACH CHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 22039144 ↗
• MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE FOUR INNER TUBES WERE EXTREMELY TIGHT, PATIENT UNABLE TO TURN INDEPENDENTLY ONCE INSERTED. FURTHER TUBES WERE OPENED OF SAME BATCH. AGAIN SAME ISSUES. FULL EMERGENCY CHANGE WERE REQUIRED, AND PATIENT WAS DISTRESSED FROM THE EVENT.

  Patient problems: Distress; Unintended Extubation

  MAUDE report 21941838 ↗
• MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE FOUR INNER TUBES WERE EXTREMELY TIGHT, PATIENT UNABLE TO TURN INDEPENDENTLY ONCE INSERTED. FURTHER TUBES WERE OPENED OF SAME BATCH. AGAIN SAME ISSUES. FULL EMERGENCY CHANGE WERE REQUIRED, AND PATIENT WAS DISTRESSED FROM THE EVENT.

  Patient problems: Distress; Unintended Extubation

  MAUDE report 21941728 ↗
• MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE FOUR INNER TUBES WERE EXTREMELY TIGHT, PATIENT UNABLE TO TURN INDEPENDENTLY ONCE INSERTED. FURTHER TUBES WERE OPENED OF SAME BATCH. AGAIN SAME ISSUES. FULL EMERGENCY CHANGE WERE REQUIRED, AND PATIENT WAS DISTRESSED FROM THE EVENT.

  Patient problems: Distress; Unintended Extubation

  MAUDE report 21941703 ↗
• InjuryMay 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE FOUR INNER TUBES WERE EXTREMELY TIGHT, PATIENT UNABLE TO TURN INDEPENDENTLY ONCE INSERTED. FURTHER TUBES WERE OPENED OF SAME BATCH. AGAIN SAME ISSUES. FULL EMERGENCY CHANGE WERE REQUIRED, AND PATIENT WAS DISTRESSED FROM THE EVENT.

  Patient problems: Distress; Unintended Extubation

  MAUDE report 21941658 ↗
• MalfunctionApr 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USE, THE TRACHEOSTOMY TUBE WAS LEAKING AND WOULD NOT STAY INFLATED. THE SAME ISSUE WAS OBSERVED WITH THE CURRENT TRACHEOSTOMY TUBE BEING USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903415 ↗
• MalfunctionApr 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USE, THE TRACHEOSTOMY TUBE WAS LEAKING AND WOULD NOT STAY INFLATED. THE SAME ISSUE WAS OBSERVED WITH THE CURRENT TRACHEOSTOMY TUBE BEING USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903068 ↗
• MalfunctionMar 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A TRACHEOSTOMY CANNULA HAD ISSUES WITH THE INNER TUBE NOT BEING ABLE TO TURN AND BECOMING COMPLETELY STUCK. THIS PROBLEM REQUIRED CONTINUOUS LOOSENING AND TURNING BACK AND FORTH PRIOR TO THE INSERTION OF THE TRACHEOSTOMY. THE ISSUE OCCURRED IN A HOSPITAL SETTING AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21727302 ↗
• MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER TUBE WAS VERY TIGHT. EVEN WHEN IT WAS CHANGED WITH ANOTHER PACK OF THE INNER TUBE, IT WAS STILL TIGHT. THE TWO DOTS DID NOT MEET. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643222 ↗
• MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER TUBE WAS VERY TIGHT. EVEN WHEN IT WAS CHANGED WITH ANOTHER PACK OF THE INNER TUBE, IT WAS STILL TIGHT. THE TWO DOTS DID NOT MEET, AS SHOWN IN THE ATTACHED PHOTO. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642554 ↗
• MalfunctionMar 11, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE INNER CANNULA OF THE TRACHEOSTOMY TUBE WAS LOOSE AND WAS UNABLE TO LOCK AS SHOWN IN THE ATTACHED VIDEO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569887 ↗
• MalfunctionMar 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA FLANGE DETACHED FROM SHAFT UPON OPENING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503960 ↗
• MalfunctionMar 3, 2025Crack; Crack

  IT WAS REPORTED THAT THE TRACHEOSTOMY CANNULA EXPERIENCED A SHAFT CRACK UPON OPENING AT A CHAIN DRUG STORE. THE PRODUCT WAS NEWLY OPENED WHEN THE BREAKAGE WAS OBSERVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503944 ↗
• MalfunctionDec 3, 2024Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE BROKE INTO TWO SEPARATE PIECES. FLANGE SEPARATED FROM OUTER PART OF TRACH TUBE. NEW TUBE RE-CANNULATED, SECURED WITH BOTH VELCRO TIES AND TWILL TIES, AND THEN APPROPRIATELY RESTRAINED.

  Patient problems: Unintended Extubation

  MAUDE report 20834156 ↗
• MalfunctionNov 27, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE FLANGE OF THE TRACHEOSTOMY TUBE WAS DETACHED FROM THE SHAFT WITHIN ONE WEEK OF PATIENT USE. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 20801432 ↗
• MalfunctionOct 14, 2024Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD A BREAKAGE AT THE DISTAL CONNECTOR. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20446277 ↗
• MalfunctionOct 9, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE TRACHEOSTOMY TUBE'S 15MM CONNECTOR WAS FOUND CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410559 ↗
• InjurySep 12, 2024Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT HAD DIFFICULTY BREATHING AND WAS UNABLE TO SPIT AND EXPECTORATE WHILE USING THE TRACHEOSTOMY TUBE. IT WAS STATED THAT IT CAUSED WHISTLING SOUNDS WHEN THE PATIENT BREATHE. THE PATIENT HAD A REPLACEMENT OF THE TUBE AND RESOLVED THE ISSUE.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 20198420 ↗
• InjurySep 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT HAD DIFFICULTY BREATHING AND WAS UNABLE TO SPIT AND EXPECTORATE WHILE USING THE TRACHEOSTOMY TUBE. IT WAS STATED THAT IT CAUSED WHISTLING SOUNDS WHEN THE PATIENT BREATHE. THE PATIENT HAD A REPLACEMENT OF THE TUBE AND RESOLVED THE ISSUE.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 20180587 ↗

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-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-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-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-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-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-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-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
• 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-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-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-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-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

…and 8 more.