Shiley 6DCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 20884522029015), received between Mar 29, 2017 and May 6, 2022 — classified as 1 death, 14 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (8 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Connection Problem; Material Split, Cut or Torn; Connection Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S PEG THAT HOLD THE TRACH BROKE. INNER CANNULA WAS CHANGED.

  Patient problems: Unintended Extubation

  MAUDE report 14309406 ↗
• MalfunctionMar 28, 2022Use of Device Problem; Connection Problem; Material Split, Cut or Torn; Use of Device Problem; Connection Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S PEG THAT HOLD THE TRACH BROKE. EXTERNAL BALLOON NOT EVEN THOUGH CUFF WAS INFLATING. INNER CANNULA WAS CHANGED.

  Patient problems: Unintended Extubation

  MAUDE report 13930551 ↗
• MalfunctionDec 15, 2021Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING USE, THE TRACH BROKE. THE PATIENT REQUIRED REINTUBATION.

  Patient problems: Unintended Extubation

  MAUDE report 13009532 ↗
• MalfunctionOct 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE WAS DAMAGED OR BROKEN. THE PATIENT HAD A REPLACEMENT OF THE TUBE WITH NO HARM.

  Patient problems: Unintended Extubation

  MAUDE report 12678170 ↗
• MalfunctionOct 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE WAS DAMAGED OR BROKEN. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 12678165 ↗
• MalfunctionJul 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE OUTER FLANGE BROKE OFF AND NOT ALLOWING VENT OR INNER CANNULA TO BE SECURE. THE TRACH WAS BROKEN WHEN THE PATIENT TURNED ON THE SIDE, INNER CANNULA CONTINUOUSLY CAME OUT. TRACH WAS EXCHANGED AT THE BESIDE WITH NO HARM TO THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 12200896 ↗
• MalfunctionDec 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT INFLATE OR STAY INFLATED. DEVICE FAILED PRIOR TO INSERTION, THUS IT WAS NOT USED ON THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094756 ↗
• MalfunctionDec 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT INFLATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094704 ↗
• InjuryDec 8, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD FAILURE; THERE WAS AIR AND IT WOULD NOT DEFLATE. PATIENT HAD BEEN USING A CUFFED DEVICE FOR OVER A YEAR AND WOULD GO TO THE HOSPITAL TO CHANGE IT EVERY SIX WEEKS TO TWO MONTHS. WHEN PATIENT WOKE UP AFTER INSERTION, PATIENT WAS NOT COMFORTABLE -- IT WAS AS THOUGH THE DEVICE WAS INFLATED TOO MUCH. WHEN PATIENT WENT HOME, DEVICE WAS INFLATED AND ATTACHED TO BIPAP, THEN DEFLATED IT IN THE MORNING. IT FELT LIKE PATIENT COULD NOT BREATHE PROPERLY AND THAT DEVICE MAY NOT BE DEFLATING. PATIENT PURCHASED THE DEVICE PRIOR TO PROCEDURE AND BROUGHT IT TO INSERTION.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 10964679 ↗
• InjuryOct 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD A WOUND AT THE SITE OF THE FLANGE. THE PATIENT WAS SAID TO HAVE A LOW ALBUMIN WHICH WAS AT 2.6 AND WAS NOT SEPTIC. SUPPORT ARM WAS USED BUT THE DRESSING DID NOT FOUND. THE PATIENT HAD EXTUBATED.

  Patient problems: Wound Dehiscence

  MAUDE report 10725894 ↗
• InjuryOct 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD A WOUND AT THE SITE OF THE FLANGE. IT WAS STATED THAT THE DEVICE WAS SUTURED SO CLOSELY THAT THE PIECE OF GAUZE UNDER THE PLATE WAS DIFFICULT TO GET. THE PATIENT WAS SAID TO HAVE A LOW ALBUMIN WHICH WAS AT 1.9 AND ALSO BEEN SEPTIC PRIOR TO WOUND DISCOVERY.

  Patient problems: Wound Dehiscence

  MAUDE report 10725785 ↗
• InjuryJul 17, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A CANNULA CHANGE 3 WEEKS AGO. IT WAS INDICATED THAT IT WAS BECAUSE THE CUFF EMPTIED EVERY HALF HOUR. THE HOSPITAL INDICATED THAT THE CUFF HAD NO LEAKAGE. IN ADDITION THEY RECEIVED THE OLD CANNULA BACK IN A CONTAINER OF WATER. THERE WAS NO LEAKAGE IN THE BALLOON, HOWEVER A BUBBLE DID COME FROM THE VALVE. IT WAS STATED THAT THIS WAS THE 3RD OR 4TH TIME THIS HAD HAPPENED.

  Patient problems: Extubate

  MAUDE report 10290716 ↗
• MalfunctionJun 24, 2020Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF HAD A SLOW TINY LEAKAGE AND REFILLED BY AIR OF THE VENTILATOR. THE CUFF WAS STATED LOSING PRESSURE SLOWLY UNTIL THE PRESSURE OF THE VENTILATOR WOULD PASSED THE CUFF AND CREATED A HISSING NOISE AT THE STOMA. NECESSARY TO CHECK THE CUFF EVERY THREE HOURS TO KEEP IT PROPERLY INFLATED. REPLACEMENT OF THE TUBE WAS ORDERED IF FREQUENCY OF CHECKING IS TOO QUICK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10189340 ↗
• InjuryDec 8, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE COMPONENT WHICH WAS USED TO HOLD INNER CANNULA IN PLACE BROKE OFF. IT WAS INDICATED THAT PATIENT WAS RETRACHED.

  Patient problems: Extubate

  MAUDE report 9435181 ↗
• InjuryDec 8, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE COMPONENT WHICH WAS USED TO HOLD INNER CANNULA IN PLACE BROKE OFF. IT WAS INDICATED THAT PATIENT WAS RETRACHED.

  Patient problems: Extubate

  MAUDE report 9435177 ↗
• InjuryDec 8, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE COMPONENT WHICH WAS USED TO HOLD INNER CANNULA IN PLACE BROKE OFF. IT WAS INDICATED THAT PATIENT WAS RETRACHED.

  Patient problems: Extubate

  MAUDE report 9435172 ↗
• InjuryDec 6, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE DEVICE HAD CRACK AT THE POINT WHERE IT WAS CONNECTED TO THE FLANGE. IT WAS INDICATED THAT PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 9433629 ↗
• InjuryNov 18, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, WHEN THEY WERE ABOUT TO REMOVE THE DEVICE AND FOUND THAT THE CLIPS ON EITHER SIDE OF THE FLANGE WERE BROKEN. THEY DID NOT SLIDE INTO THE PATIENT BUT IT EXTENDED FORWARD ABOUT 1 TO 1 1/2 INCHES. THEY REMOVE THE DEVICE AND REPLACED IT.

  Patient problems: Extubate

  MAUDE report 9336716 ↗
• MalfunctionNov 4, 2019Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, WHILE PLACING THE DEVICE DURING REPLACEMENT OF THE INNER CANNULA, THE HINGES OF THE CANNULA ON BOTH SIDES DISCONNECTED FROM THE COLLAR. IT WAS REPORTED THAT THE DOCTOR REMOVED THE DEFECTIVE PIECE WITHOUT HARM TO THE PATIENT BUT THERE WAS A POTENTIAL TO BLOCK THE AIRWAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9273392 ↗
• MalfunctionOct 10, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE FLANGE OF THE DISPOSABLE TRACHEOSTOMY TUBE DISCONNECTED FROM THE CANNULA. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: No Information

  MAUDE report 9177455 ↗
• DeathJun 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, A PATIENT WAS INJURED IN A CAR WRECK AND EVENTUALLY PASSED AWAY. THE PATIENT WAS INITIALLY TREATED, WHERE SHE UNDERWENT A TRACHEOSTOMY AND RECEIVED TREATMENT FOR VARIOUS INJURIES SUFFERED IN THE WRECK. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER HOSPITAL, AFTER WHICH SHE WAS TRANSFERRED AGAIN, WHERE SHE RECOVERED FROM THE PRIMARY ACUTE INJURIES SUFFERED IN THE WRECK. THE PATIENT THEN REQUIRED TRANSPORT TO A SKILLED NURSING FACILITY FOR THE PURPOSE OF DECANNULATION. THE PATIENT ENCOUNTERED DIFFICULTY BREATHING WHILE AT THE SKILLED NURSING FACILITY ON NUMEROUS OCCASIONS. THE INNER CANNULA OF THE TRACHEOSTOMY WAS TO BE CHANGED TWICE DAILY AT THE FACILITY, BUT IT WAS REPORTED THAT THIS DID NOT OCCUR. THE PATIENT WAS FOUND NOT BREATHING AND WAS UNRESPONSIVE. AN AMBULANCE WAS DISPATCHED TO THE FACILITY AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED ON THE PATIENT. THE EMERGENCY MEDICAL TECHNICIAN (EMT) SUCTIONED THE PATIENT'S TRACHEOSTOMY TUBE AND REMOVED 30 CC OF MUCUS FROM THE TUBE. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL AND WAS PRONOUNCED DEAD. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Death

  MAUDE report 8676973 ↗
• MalfunctionApr 19, 2019Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD BEEN USED FOR THREE WEEKS AND NOTICED THAT CUFF SLOWLY DEFLATES BUT NOT TO THE POINT THAT THE VENTILATOR WOULD ALARM. THE DEVICE WAS INFLATED WITH 8-9ML OF AIR. THE PATIENT HAS NOT BEEN DE-CANNULATED AND THERE WAS NO HARMNOTED. THE CUFF CONSTANTLY RE-INFLATED TO RESOLVED THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8532031 ↗
• InjuryJan 13, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE DEVICE WAS MALFORMED. THE CUSTOMER INDICATED THAT THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 8243055 ↗
• MalfunctionSep 26, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, THE DEVICE'S OBTURATOR WAS NOT SEATED CORRECTLY. IT WAS REPORTED THAT THE OBTURATOR LOOKED LIKE A LITTLE LONGER. A CUSTOMER REPORTED THAT THE PATIENT WAS INTUBATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910628 ↗
• InjuryJun 11, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE'S SIDE OF THE HUB BROKE OFF SO THERE WAS NOTHING ATTACHED TO THE INNER CANNULA. THE CUSTOMER REPORTED THAT THEY REPLACED THE TRACHEOSTOMY TUBE.

  Patient problems: Extubate

  MAUDE report 7587320 ↗

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

…and 8 more.