Shiley 8DFENRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884522006675), received between May 1, 2018 and May 6, 2025 — classified as 10 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 23, 2026Open, Classified

   Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

   Z-2653-2026 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT THE TRACH INTO THE AIRWAY, THE FLANGE BROKE AWAY FROM THE TUBE, MAKING IT AN UNUSABLE AIRWAY (THE TRACH WAS LEFT IN THE AIRWAY TO ENSURE THE INCISION STAYED OPEN). THE PATIENT REMAINED STABLE WITH AN ENDOTRACHEAL TUBE STILL IN HIS AIRWAY. DUE TO THE POTENTIAL THAT THE ENDOTRACHEAL TUBE COULD BE RIGHT AT THE VOCAL CORDS VS THROUGH THE VOCAL CORDS, ANESTHESIA WAS CALLED TO BEDSIDE TO ASSIST. ANESTHESIA SHOWED UP TO ASSIST IN ENSURING THE ENDOTRACHEAL TUBE WAS IN CORRECT PLACEMENT PRIOR TO DOCTOR EXCHANGING THE TRACHEOSTOMY TUBE. THE TRACHEOSTOMY TUBE WAS EXCHANGED WITH NO ISSUES. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE.

  Patient problems: Unintended Extubation

  MAUDE report 21970015 ↗
• MalfunctionMar 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A DEFECTIVE TRACHEOSTOMY TUBE WAS USED ON A PATIENT DURING AN INTRA-OPERATIVE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501266 ↗
• MalfunctionFeb 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A DEFECTIVE TRACHEOSTOMY TUBE WAS USED ON A PATIENT DURING A PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 21444757 ↗
• MalfunctionJun 21, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TRACHEOSTOMY CANNULA FAILED TO MAINTAIN ADEQUATE CUFF PRESSURE. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19590095 ↗
• MalfunctionJan 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING BRONCHIAL HYGIENE, THE TOP OF THE CANULA WAS FOUND DEPRESSED. A REQUEST FOR A NEW TRACHEOSTOMY TUBE WAS MADE TO THE PHARMACY AREA SO THAT A CHANGE COULD BE MADE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18530035 ↗
• MalfunctionNov 2, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS LOOSE AND DETACHED FROM ITS SUPPORT DURING PROCEDURE. THE TUBE WAS NOT SEPARATED FROM THE HUB AND THERE WAS A VISIBLE PLASTIC SUPPORT DEFECT. THE TRACHEOSTOMY REFITTED AT D4. REPLACEMENT OF THE TUBE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Unintended Extubation

  MAUDE report 18057700 ↗
• MalfunctionOct 22, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT BALLOON DID NOT INFLATE WHEN TESTED AND A BALLOON "RUPTURE" WAS EVIDENT BEFORE USE. A NEW CANNULA WAS REQUESTED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982320 ↗
• MalfunctionSep 15, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY CANNULA'S FLANGE COMPLETELY SEPARATED FROM THE HUB. A DECANNULATION HAD TO BE PERFORM ALONG WITH A TUBE REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 17761314 ↗
• MalfunctionApr 22, 2022Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CANNULAS ARE OUT OF ALIGNMENT AND IT WAS INSERTED FOR ONLY 15 SECONDS. IT COULD NOT BE TRACED WHY THERE WAS A DROP IN SPO2 WHEN THE OO2 SPEAKER ATTACHMENT WAS APPLIED (PHONATE SPEAKING VALVE FOR USE WITH LOW-FLOW OXYGEN PORT). THE PATIENT WAS DECANNULATED.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 14187746 ↗
• MalfunctionApr 22, 2022Use of Device Problem; Defective Component; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CANNULAS ARE OUT OF ALIGNMENT AND IT WAS INSERTED FOR ONLY 15 SECONDS. IT COULD NOT BE TRACED WHY THERE WAS A DROP IN SPO2 WHEN THE OO2 SPEAKER ATTACHMENT WAS APPLIED (PHONATE SPEAKING VALVE FOR USE WITH LOW-FLOW OXYGEN PORT). FURTHERMORE, IT WAS DETERMINED THAT THE PATIENT EXPERIENCED DYSPNEA. THE PATIENT WAS DECANNULATED.

  Patient problems: Dyspnea; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 14187597 ↗
• InjuryJan 6, 2022Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE'S INNER CANNULA CAME OUT ALLOWING THE PHYSICIAN TO SEE THAT THE LOCKING CONNECTOR WAS GONE WHICH PREVENTING THE CANNULA FROM BEING RETAINED ON THE CLIP AND PROPER ARTIFICIAL VENTILATION IMPOSSIBLE. IT WAS STATED THAT THE PATIENT HAD A HYPOXIC HEART FAILURE. A CARDIAC MASSAGE WAS PERFORMED AND THE PATIENT HAD A CANNULA REPLACEMENT.

  Patient problems: Hypoxia

  MAUDE report 13177865 ↗
• InjuryNov 29, 2021Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA BODY SEPARATED FROM THE CANNULA BASE. IT PROTRUDES BY 1 CENTIMETER RESULTING BLOOD LOSS WITHOUT SERIOUS CONSEQUENCES TO THE PATIENT. THE CANNULA WAS REMOVED AND REPLACED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12881947 ↗
• MalfunctionSep 22, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING TRACHEOSTOMY AND PERCUTANEOUS ENDOSCOPIC GASTROSTOMY, THE BALLOON OF THE DEVICE HAD A HOLE. A SECOND DEVICE WAS OPENED AND THE BALLOON HAD A HUGE HOLE AS WELL. A DIFFERENT SIZE OF THE TUBE WAS OBTAINED AND PLACED WITH NO ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 12517055 ↗
• MalfunctionSep 22, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING TRACHEOSTOMY AND PERCUTANEOUS ENDOSCOPIC GASTROSTOMY, THE BALLOON OF THE DEVICE HAD A HOLE. A SECOND DEVICE WAS OPENED AND THE BALLOON HAD A HUGE HOLE AS WELL. A DIFFERENT SIZE OF THE TUBE WAS OBTAINED AND PLACED WITH NO ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 12517036 ↗
• MalfunctionAug 27, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD HOLES IN THE BALLOONS. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12380937 ↗
• MalfunctionAug 27, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD HOLES IN THE BALLOONS. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12380935 ↗
• InjuryAug 25, 2020Component Missing; Component Missing

  ACCORDING TO THE REPORTER, THE DEVICE HAD A MISSING INTERNAL SLEEVE DURING THE INSERTION OF THE INNER CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 10451726 ↗
• MalfunctionJul 17, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE.THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10291868 ↗
• InjuryAug 16, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE TUBE SEPARATED FROM THE FLANGE AND HANGING APPROXIMATELY 1-2 CM. THE FLANGE WAS STILL SUTURED TO THE PATIENT. THE INNER CANNULA WAS STILL WITHIN THE TRACH TUBE AND STILL ATTACHED TO THE VENTILATOR. UPON FURTHER INSPECTION, IT APPEARED THAT THE FITTINGS HAD BROKEN. THE OLD TRACH WAS CHANGED OUT AND PLACED THE NEW TRACH INTO THE STOMA.

  Patient problems: Extubate

  MAUDE report 8903288 ↗
• InjuryAug 5, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE THE FLANGE OF THE TRACHEOTOMY TUBE COMPLETELY DETACHED FROM THE TUBE ABOUT 12 HOURS AFTER THE TUBE WAS PLACED. UNSURE OF HOW IT OCCURRED, BUT WHEN THE PATIENTS WERE CHECKED ON BY STAFF THE FLANGE WAS COMPLETELY DETACHED. THE TUBE WAS THEN THROWN AWAY BY THE CLINICIAN AND THEN REPLACED WITH AN XLT TRACH. DECANNULATION/REINTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 8862672 ↗
• InjuryMay 14, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A CUFF INFLATION/DEFLATION ISSUE. THE BALLOONS OF THE CANNULAS DEFLATE AFTER LESS THAN A WEEK OF APPLICATION. THIS OCCURRED WITH 4 DEVICES. THE PATIENT USED A DEVICE FROM ANOTHER LOT NUMBER AND EVERYTHING WENT WELL.

  Patient problems: Extubate

  MAUDE report 8610089 ↗
• InjuryMay 14, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A CUFF INFLATION/DEFLATION ISSUE. THE BALLOONS OF THE CANNULAS DEFLATE AFTER LESS THAN A WEEK OF APPLICATION. THIS OCCURRED WITH 4 DEVICES. THE PATIENT USED A DEVICE FROM ANOTHER LOT NUMBER AND EVERYTHING WENT WELL.

  Patient problems: Extubate

  MAUDE report 8610004 ↗
• InjuryMay 14, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A CUFF INFLATION/DEFLATION ISSUE. THE BALLOONS OF THE CANNULAS DEFLATE AFTER LESS THAN A WEEK OF APPLICATION. THIS OCCURRED WITH 4 DEVICES. THE PATIENT USED A DEVICE FROM ANOTHER LOT NUMBER AND EVERYTHING WENT WELL.

  Patient problems: Extubate

  MAUDE report 8609960 ↗
• InjuryMay 14, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A CUFF INFLATION/DEFLATION ISSUE. THE BALLOONS OF THE CANNULAS DEFLATE AFTER LESS THAN A WEEK OF APPLICATION. THIS OCCURRED WITH 4 DEVICES. THE PATIENT USED A DEVICE FROM ANOTHER LOT NUMBER AND EVERYTHING GOES WELL.

  Patient problems: Extubate

  MAUDE report 8609729 ↗
• MalfunctionJun 7, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, A WHISTLE WAS FELT/HEARD COMING FROM THE TUBE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7578293 ↗

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

…and 8 more.