Shiley 8FENRecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 60884522007035), received between Jun 12, 2017 and Jan 21, 2026 — classified as 2 deaths, 9 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (19 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFFS DID NOT INFLATE DESPITE MULTIPLE ATTEMPT, DURING USE AT A HOSPITAL. THE TUBES WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24140254 ↗
• MalfunctionJan 21, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFFS DID NOT INFLATE DESPITE MULTIPLE ATTEMPT, DURING USE AT A HOSPITAL. THE TUBES WERE REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24140248 ↗
• MalfunctionOct 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE THREE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363754 ↗
• MalfunctionOct 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE THREE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363749 ↗
• MalfunctionOct 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INNER CANNULAS OF THE THREE TRACHEOSTOMY TUBES HAD AN UNEVEN END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363700 ↗
• MalfunctionAug 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATION, THE TRACH TUBE'S CUFF DID NOT INFLATE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22728803 ↗
• MalfunctionJan 7, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21091531 ↗
• MalfunctionJan 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS BROKEN UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076215 ↗
• MalfunctionDec 30, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE GREEN CAP OF THE INNER CANNULA WAS NOT CLOSING TIGHTLY WHICH CAUSING AIR TO LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21042987 ↗
• MalfunctionOct 30, 2024Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA'S FENESTRATION WAS SLIGHTLY DEFORMED AFTER EXTUBATION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566923 ↗
• MalfunctionJun 18, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA'S CUFF HAD AN AIR LEAK ON THE FIRST DAY OF PATIENT USE. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19564050 ↗
• MalfunctionFeb 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A SIGNIFICANT LEAK WAS OBSERVED DURING VENTILATION. THE INNER LINER WAS CHANGED BUT STILL HAD PERSISTENT LEAKS ON VENTILATOR AND FIBERSCOPE. THE TRACHEOSTOMY CANNULA WAS CHANGED.

  Patient problems: Unintended Extubation

  MAUDE report 18813624 ↗
• MalfunctionFeb 27, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789807 ↗
• InjuryFeb 20, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA BROKE IN THE MIDDLE ON THE FIFTH DAY OF USAGE, AS SHOWN IN THE ATTACHED VIDEO, WHICH MADE THE OXYGEN FLOW NOT REACH ITS MAXIMUM THROUGH THE PATIENT'S LUNGS AND CAUSE HER TO NOT BREATHE NORMALLY. THE PATIENT CONTINUED USING THE DEVICE IN THE ICU. ENT SPECIALIST CONVEYED ABOUT THE CANNULA TREATMENT.

  Patient problems: Dyspnea; Hypoventilation

  MAUDE report 18743511 ↗
• MalfunctionSep 29, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACH'S CUFF HAD A DEFLATION ISSUE DURING PRE-INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849010 ↗
• InjurySep 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT WAS FOUND "HUSTLING AND BUSTLING IN BED", SEVERAL TIMES REMOVED THE CONNECTOR FROM THE VENTILATOR, HAD A DESATURATION, AND THE READING DROPPED TO 85%, REPOSITIONED SEVERAL TIMES, ASPIRATED THICK SECRETIONS, AND BLOOD STREAKS. WHEN ENTERING THE ROOM, THE PATIENT WAS VISIBLY CYANOTIC, WITH MARKED DESATURATION UP TO 77%. THE PATIENT VOLUNTARILY REMOVED THE TRACHEAL TUBE, NASOGASTRIC TUBE, AND DENTURE ATTEMPTS TO REPOSITION THE CANNULA IMMEDIATELY WITHOUT SUCCESS. THE TUBE WAS PLACED IN THE TRACHEAL STOMA AND WAS CONNECTED TO THE OXYGEN, WITH SOME RESUMPTION OF SPO2, BUT ALERTED THE RESUSCITATOR. THE PATIENT WAS SEDATED WITH PROPOFOL WITH VENTILATION MAINTAINED, AND AN ABUNDANCE OF BLOOD SECRETIONS WERE ASPIRATED WITH THE USE OF A CANNULA GUIDE. THE PATIENT WAS ALERT, STILL AGITATED, AND BUSY AS A SIDE EFFECT OF THE SEDATION. THE PATIENT WAS RESTRAINED, REPOSITIONING WAS DONE AGAIN, AND IT SHOWED A RISE IN SPO2 TO 88%. FACE MR WAS GIVEN AT 15 LT/M WITH THE FINAL SPO2 OF 89¿90%. EXTEMPORANEOUS AEROSOL WAS GIVEN WITH ATEM, CLENIL, BRONCOVALEAS, AND SPO2 UP TO 94%, BUT THE PATIENT STILL HAD TACHYCARDIA WITH UP TO 160 BPM. THE PATIENT WAS APYRETIC IN

  Patient problems: Low Oxygen Saturation

  MAUDE report 17732530 ↗
• MalfunctionSep 6, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH CANNULA'S CUFF HAD AN AIR LEAK AFTER ONE DAY OF PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17695130 ↗
• MalfunctionSep 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT VALVE OF THE TRACH CANNULA WAS HAVING ISSUE INFLATING OR DEFLATING THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686942 ↗
• MalfunctionMay 12, 2023Use of Device Problem; Defective Component; Material Split, Cut or Torn; Use of Device Problem; Defective Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INNER CANNULA WAS DEFORMED AND HAD A GAP THAT CAUSED AIR LEAK PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16922041 ↗
• MalfunctionMar 10, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AN AIR LEAK BEFORE USE AND WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524754 ↗
• MalfunctionMar 10, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE'S PILOT LINE CONNECT POINT WITH THE TUBE FELL OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522130 ↗
• MalfunctionOct 29, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD INFLATED AND DEFLATION ISSUE AND FOUND THAT THE CUFF HAD A LEAK. THE CUFF INFLATED AND DEFLATED DURING PRETEST WITH THE USED OF SYRINGE WITH 25 CC OF WATER. RECANNULATION WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 15695813 ↗
• MalfunctionOct 28, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE WAS INFLATED AND DEFLATED DURING PRETEST WITH THE USED OF SYRINGE WITH 25 CC OF WATER. BUT, DURING USE, THE CUFF HAD INFLATION AND DEFLATION ISSUE. REINTUBATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 15694172 ↗
• MalfunctionOct 26, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF WAS PRE-TESTED WITH ABOUT 25 CM H2O USING A SYRINGE AND THE CUFF INFLATED AND DEFLATED WITH NO ISSUE. HOWEVER, DURING USE, THE CUFF DID NOT INFLATE DUE TO CUFF LEAK. RECANNULATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 15672797 ↗
• MalfunctionJun 2, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, BEFORE PLACING THE DEVICE IN THE PATIENT, THE DOCTOR NOTICED THAT THE CUFF OF THE DEVICE DID NOT HAVE THE NATURAL CONICAL OR OVAL SHAPE THAT THESE DEVICES GENERALLY HAD AND THAT AN UNNATURAL SWELLING WAS OBSERVED ON ONE OF ITS SIDES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575233 ↗

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-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
• 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-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-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-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-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-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-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-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-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-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-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-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-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,

…and 8 more.