Shiley 8DCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 20884522029022), received between May 4, 2017 and Sep 15, 2022 — classified as 2 deaths, 52 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Disconnection” (33 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 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE "FITANGE" BECAME DISCONNECTED FROM THE ACTUAL AIRWAY CANNULA MAKING THE TUBE DIFFICULT TO SECURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15427206 ↗
• InjuryMay 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A PATIENT WENT TO THE OPERATION ROOM FOR A TRACHEOSTOMY DUE TO SEVERE COVID AND RESPIRATORY FAILURE. DURING TRACH PLACEMENT, THE TRACHEOSTOMY WAS PLACED AND THE TRACHEOSTOMY WAS NOTED TO BE DOWN AFTER INFLATION AND THERE WAS CONCERN FOR A DAMAGED CUFF. GIVEN THAT THE CUFF WAS TORN THE PATIENT WAS RE-INTUBATED WITH ENDOTRACHEAL TUBE (ETT) THAT WAS STILL IN UPPER TRACHEA AND THE TRACHEOSTOMY WAS REMOVED. THE PATIENT THEN RECOVERED AS THE PATIENT HAD VERY POOR PULMONARY RESERVE AND A NEW TRACHEOSTOMY WAS PLACED. THIS CUFF WAS CHECKED PRIOR TO PLACEMENT BUT AGAIN WAS TORN FOLLOWING PLACEMENT. THE PATIENT'S SPO2 REMAINED AT 95% AND A NEW TRACHEOSTOMY WAS PREPARED TO BE PLACED. WHEN AWAITING A NEW TRACHEOSTOMY THE PATIENT WAS NOTED TO LOSE SPO2 AND GO INTO VENTRICULAR FIBRILLATION. THE ETT WAS AGAIN PLACED AND THE TRACHEOSTOMY WITH BROKEN CUFF WAS REMOVED. ADVANCE CARDIOVASCULAR LIFE SUPPORT (ACLS) COMMENCED AND THE PATIENT UNDERWENT MULTIPLE ROUNDS OF CARDIOPULMONARY RESUSCITATION (CPR). AFTER CPR WAS COMMENCED LAST T IME, THE PATIENT THEN BEGAN TO HAVE MASSIVE HEMOPTYSIS FROM HER ETT WITH INABILITY TO VENTILATE. RESUSCITATIVE EFFORTS CEASED AFTER DISCUSSION W

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 14490208 ↗
• DeathMay 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A PATIENT WENT TO THE OPERATION ROOM FOR A TRACHEOSTOMY DUE TO SEVERE COVID AND RESPIRATORY FAILURE. DURING TRACH PLACEMENT, THE TRACHEOSTOMY WAS PLACED AND THE TRACHEOSTOMY WAS NOTED TO BE DOWN AFTER INFLATION AND THERE WAS CONCERN FOR A DAMAGED CUFF. GIVEN THAT THE CUFF WAS TORN THE PATIENT WAS RE-INTUBATED WITH ENDOTRACHEAL TUBE (ETT) THAT WAS STILL IN UPPER TRACHEA AND THE TRACHEOSTOMY WAS REMOVED. THE PATIENT THEN RECOVERED AS THE PATIENT HAD VERY POOR PULMONARY RESERVE AND A NEW TRACHEOSTOMY WAS PLACED. THIS CUFF WAS CHECKED PRIOR TO PLACEMENT BUT AGAIN WAS TORN FOLLOWING PLACEMENT. THE PATIENT'S SPO2 REMAINED AT 95% AND A NEW TRACHEOSTOMY WAS PREPARED TO BE PLACED. WHEN AWAITING A NEW TRACHEOSTOMY THE PATIENT WAS NOTED TO LOSE SPO2 AND GO INTO VENTRICULAR FIBRILLATION. THE ETT WAS AGAIN PLACED AND THE TRACHEOSTOMY WITH BROKEN CUFF WAS REMOVED. ADVANCE CARDIOVASCULAR LIFE SUPPORT (ACLS) COMMENCED AND THE PATIENT UNDERWENT MULTIPLE ROUNDS OF CARDIOPULMONARY RESUSCITATION (CPR). AFTER CPR WAS COMMENCED LAST TIME, THE PATIENT THEN BEGAN TO HAVE MASSIVE HEMOPTYSIS FROM HER ETT WITH INABILITY TO VENTILATE. RESUSCITATIVE EFFORTS CEASED AFTER DISCUSSION WI

  Patient problems: Cardiac Arrest; Hemoptysis; Low Oxygen Saturation; Unintended Extubation; Ventricular Fibrillation

  MAUDE report 14490194 ↗
• MalfunctionMay 23, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS LOSS OF AIR FROM THE CUFF WELD, WITH RELATIVE ACTIVATION OF THE PRESSURE/VOLUME ALARMS OF THE VENTILATOR. IT WAS NOTED THAT THERE WERE NO VISIBLE HOLES. RECANNULATION WAS REQUIRED, AS THE PATIENT IS AN ALS (AMYOTROPHIC LATERAL SCLEROSIS) VENTILATED PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 14469301 ↗
• MalfunctionMay 23, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS LOSS OF AIR FROM THE CUFF WELD, WITH RELATIVE ACTIVATION OF THE PRESSURE/VOLUME ALARMS OF THE VENTILATOR. IT WAS NOTED THAT THERE WERE NO VISIBLE HOLES. RECANNULATION WAS REQUIRED, AS THE PATIENT IS AN ALS (AMYOTROPHIC LATERAL SCLEROSIS) VENTILATED PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 14469288 ↗
• MalfunctionMar 23, 2022Disconnection; Disconnection

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE DEVICE'S OUTER CANNULA HAD TWO POSTS ON EITHER SIDE THAT SEAT IN THE NECKPLATE. WHEN ONE SIDE BECOMES DISLODGED, IT ALLOWS THE OTHER SIDE TO DISCONNECT AS WELL OFF THE NECKPLATE WHERE THE TUBE SWIVELS. THE PATIENT HAD A REPLACEMENT OF THE TUBE AND WAS TRANSFERRED TO LTAC FOR FURTHER CARE.

  Patient problems: Unintended Extubation

  MAUDE report 13868949 ↗
• MalfunctionMar 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE CAME APART IN PLACES. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 13790648 ↗
• MalfunctionMar 16, 2022Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE CAME APART IN PLACES. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 13790624 ↗
• MalfunctionMar 16, 2022Disconnection; Disconnection

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE DEVICE'S OUTER CANNULA HAD TWO POSTS ON EITHER SIDE THAT SEAT IN THE NECKPLATE. WHEN ONE SIDE BECOMES DISLODGED, IT ALLOWS THE OTHER SIDE TO DISCONNECT AS WELL OFF THE NECKPLATE WHERE THE TUBE SWIVELS. THE PATIENT HAD A REPLACEMENT OF THE TUBE. THE FAMILY MADE DNR AND COMFORT CARE AFTER TUBE REPLACEMENT AND UNABLE TO KEEP PATIENT SATURATION.

  Patient problems: Unintended Extubation

  MAUDE report 13790574 ↗
• MalfunctionOct 26, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE FLANGE WAS SEPARATED FROM HUB DURING INSERTION ON PATIENT, BUT THE HUB DID NOT SEPARATE INTO TWO PIECES. RE-CANNULATION WAS REQUIRED BUT THERE WAS NO PATIENT CONSEQUENCES RELATED TO THE EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 12697587 ↗
• MalfunctionOct 26, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE FLANGE SEPARATED FROM THE HUB AND INNER TUBE DURING INSERTION. A DILATOR WAS USED FOR INITIAL INSERTION DUE TO PROCEDURE. A NEW TRACH WAS PLACED.

  Patient problems: Unintended Extubation

  MAUDE report 12697513 ↗
• MalfunctionOct 21, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AN AUDIBLE LEAK WAS HEARD AND PATIENT WAS LOSING VT, A BLOWN CUFF WAS DISCOVERED FROM THE PATIENT TUBE. EMERGENCY TRACH CHANGE WAS DONE USING THE SAME TYPE AND SIZE OF TRACH. THE DEVICE WAS SUBMERGED WITH WATER TO LOCATE THE LEAK AND IT WAS FOUND BETWEEN THE TRACH CUFF AND PILOT AIRLINE CONNECTION.

  Patient problems: Unintended Extubation

  MAUDE report 12678013 ↗
• MalfunctionOct 18, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, AN AUDIBLE LEAK WAS HEARD AND THE PATIENT WAS LOSING TIDAL VOLUME. A BLOWN CUFF WAS DISCOVERED FROM THE PATIENT TUBE. AN EMERGENCY DEVICE CHANGE WAS DONE USING THE SAME TYPE AND SIZE OF DEVICE. THE PATIENT WAS REASSESSED AND THE TIDAL VOLUME WAS STABLED. THE DEVICE WAS SUBMERGED WITH WATER TO LOCATE THE LEAK AND IT WAS FOUND BETWEEN THE DEVICE CUFF AND PILOT AIRLINE CONNECTION.

  Patient problems: Unintended Extubation

  MAUDE report 12652818 ↗
• MalfunctionSep 29, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, AN AUDIBLE LEAK COMING FROM THE PATIENT TRACHEOSTOMY WAS HEARD. THE VENTILATOR SHOWED A LOW MINUTE VENTILATION ALARM NOTIFICATION. A VOLUME OF AIR WAS INTRODUCED TO CORRECT THE LEAK. A FEW MINUTES LATER, AN AUDIBLE LEAK WAS NOTED AGAIN. DUE TO THE MULTIPLE INTRODUCTIONS OF AIR THROUGH THE DEVICE PILOT BALLOON AND THE DEVICE NOT HOLDING VOLUME, IT WAS ASSESSED THAT THERE WAS A LEAK IN THE DEVICE. AN EMERGENCY DEVICE CHANGE WAS PERFORMED DUE TO CONSTANT INTRODUCTION OF AIR IN THE PILOT CUFF. NO ADVERSE REACTION WAS NOTED TO THE PATIENT. THE PATIENT WAS RE-ASSESSED AS NOT DISTRESSED AS NOTED VITAL SIGNS WERE STABLE.

  Patient problems: Unintended Extubation

  MAUDE report 12548696 ↗
• MalfunctionAug 26, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, AN RT HEARD AN AUDIBLE LEAK THAT CAME FROM THE PATIENT'S TRACHEOSTOMY. THE VENTILATOR SHOWED A LOW MINUTE VENTILATION AND FOLLOWED BY AN ALARM NOTIFICATION. THE VOLUME OF AIR WAS INTRODUCED TO CORRECT THE LEAK, AND A FEW MINUTES LATER THE AUDIBLE LEAK WAS NOTED AGAIN. DUE TO MULTIPLE INTRODUCTIONS OF AIR THRU TRACH PILOT BALLOON AND STILL NOT HOLDING VOLUME, IT WAS ASSESSED THAT THERE WAS A LEAK IN THE CURRENT RESIDENT TRACH. EMERGENCY TRACH CHANGED WAS PERFORMED DUE TO THE CONSTANT INTRODUCTION OF AIR IN THE PILOT CUFF.

  Patient problems: Unintended Extubation

  MAUDE report 12375231 ↗
• MalfunctionAug 3, 2021Use of Device Problem; Defective Component; Gas/Air Leak; Use of Device Problem; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LEAK. TUBE WAS REMOVED AND REPLACED WITH NEW DEVICE. THE DEVICE APPEARED TO HAD A HOLE WHERE PILOT BALLOON AND PILOT LINE WAS CONNECTED. SUBMERGED WITH WATER, TRIED TO INFLATE THE CUFF AND SAW BUBBLES OR AIR ESCAPING BETWEEN PILOT BALLOON AND PILOT LINE.

  Patient problems: Unintended Extubation

  MAUDE report 12268504 ↗
• MalfunctionAug 3, 2021Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WAS INFLATED BUT NOT HOLDING VOLUME. A LEAK WAS IDENTIFIED, TUBE WAS REMOVED AND REINSERTED A NEW ONE. THE DEVICE APPEARED TO HAD A HOLE WHERE PILOT BALLOON AND PILOT LINE WAS CONNECTED. NO FURTHER HARM WAS REPORTED TO THE PATIENT AFTER THE REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 12268308 ↗
• MalfunctionJun 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PART OF THE DEVICE THAT CONNECTS THE CANNULA TO THE SIDE PIECES THAT THE CT TIES TO WERE BROKEN. THE DEVICE WAS NOTED TO BE TOO LOOSE AND TOO TIGHT. THERE WAS A REPLACEMENT OF THE TRACHEOSTOMY TUBE BECAUSE THE AIRWAY WAS UNSTABLE DUE TO THE TRACHEOSTOMY FRACTURE. PATIENT IS STABLE AND TRANSFERRED TO ACUTE LONG TERM CARE.

  Patient problems: Unintended Extubation

  MAUDE report 12051161 ↗
• MalfunctionApr 22, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, PATIENT WENT TO OPERATING ROOM FOR PLACEMENT OF TRACHEOSTOMY TUBE AND RETURNED FOR POST-OP. WHILE PATIENT WAS BEING HOOKED BACK TO THE VENT, IT WAS NOTICED THAT THE TRACHEOSTOMY TUBE WAS FREE FLOATING IN AND OUT OF THE FLANGE. ANESTHESIA AND CRITICAL CARE TEAM USED BLUE RHINO AND STYLET TO INSERT A NEW TRACHEOSTOMY TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 11706526 ↗
• MalfunctionApr 5, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE FLANGE BROKE OFF. THE DEFECTIVE TUBE WAS REMOVED AND REPLACED WITH ANOTHER TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 11613664 ↗
• MalfunctionApr 2, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE TRACH WAS PLACED AND THE INNER CANNULA WAS PUT IN, AND THE TOP OF THE TRACH BROKE OFF. THE CANNULA WAS UNABLE TO BE SECURED. IT WAS INDICATED THAT REPLACEMENT OF TUBE WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 11607691 ↗
• MalfunctionApr 2, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE TRACH WAS PLACED AND THE INNER CANNULA WAS PUT IN, AND THE TOP OF THE TRACH BROKE OFF. THE CANNULA WAS UNABLE TO BE SECURED. IT WAS INDICATED THAT REPLACEMENT OF TUBE WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 11607626 ↗
• MalfunctionMar 17, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE UNIT FLANGE WAS BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507733 ↗
• InjuryMar 16, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE UNIT RING OF THE OUTER CANNULA WHERE THE INNER CANNULA LOCKS WAS BROKEN. THE TUBE WAS LEAKING AIR AND THEY COULD NOT GET THE CUFF TO HOLD AIR PRESSURE. TRACH WAS REMOVED AND SUBSEQUENT DAMAGE TO TRACHEAL AREA WAS DETERMINED THAT THEY NEEDED TO INTUBATE WITH AN ET TUBE. DUE TO DAMAGE TO THE TRACH AREA THE PATIENT COULD NOT BE REINTUBATED WITH A NEW TRACH TUBE. PATIENT IS CURRENTLY INTUBATED WITH AN ENDOTRACHEAL TUBE. THE PATIENT WAS ALIVE BUT WITH INJURY.

  Patient problems: Swelling/ Edema; Unintended Extubation

  MAUDE report 11490565 ↗
• MalfunctionMar 11, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, WHILE PERFORMING A TRACH CARE, IT WAS NOTICED THAT THE PATIENT'S TRACH TUBE WAS BROKEN APART FROM FLANGE. ALL PATIENT'S VITAL SIGNS WERE STABLE AND STILL ADEQUATELY VENTILATING. THERE WERE NO ISSUES DURING TRACH CHANGE.

  Patient problems: Unintended Extubation

  MAUDE report 11463017 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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

…and 8 more.