Shiley 6UN75RRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521205505), received between Oct 5, 2021 and Sep 18, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (9 reports).

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

1 other recall cover devices cleared under the same FDA submission (K150844); 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.

Recalls naming this device

1. Mar 24, 2023Open, Classified

   A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

   Z-1357-2023 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT AFTER PLACEMENT OF A NEW FLEXIBLE TRACHEOSTOMY PRODUCT, THE PATIENT FELT AS IF UNABLE TO BREATHE, DIFFICULTY COUGHING UP SECRETIONS DUE TO THE DESIGN OF THE INNER CANNULAS, A SENSATION OF CHOKING, AND ANXIETY RELATED TO THE DEVICE PROTRUDING TOO FAR FROM THE NECK. THE PATIENT ALSO REPORTED BEING UNABLE TO GO SWIMMING DUE TO THE LACK OF A CAP AND EXPERIENCED FOUR PANIC ATTACKS SINCE THE DEVICE WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Anxiety

  MAUDE report 23089494 ↗
• MalfunctionJun 28, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA WAS CLEANED WITH A 10 MM NYLON BRUSH WITH A SHARP METAL END. IT WAS FOUND OUT THAT THERE WAS A SCRATCH AND TEAR AT THE TIP OF THE INNER CANNULA, AS SHOWN IN THE ATTACHED PHOTO. THE INNER CANNULA WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639476 ↗
• MalfunctionOct 23, 2023Ambient Noise Problem; Human-Device Interface Problem; Material Split, Cut or Torn; Ambient Noise Problem; Human-Device Interface Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A POPPING SOUND WAS HEARD AND THEN AIR LEAKS IN THE AIRWAY APPROXIMATELY AN HOUR AFTER THE SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17988143 ↗
• InjurySep 18, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S FLANGE AND TUBE HAD MOLDS DURING USE, BASED ON THE PHOTO PROVIDED AND WHICH WAS SIX WEEKS AFTER INSERTION. THE PATIENT HAD A CHEST INFECTION DURING THAT PERIOD. THE TRACH WAS REMOVED AND REPLACED.

  Patient problems: Respiratory Tract Infection; Unintended Extubation; Unspecified Infection

  MAUDE report 17765951 ↗
• InjuryJun 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, A RECALLED TRACHEOSTOMY TUBE WAS IMPLANTED IN THE PATIENT, WHICH RESULTED IN A LUNG INFECTION DURING USE. THE PATIENT'S HOSPITALIZATION WAS EXTENDED FOR TEN DAYS DUE TO SORES AND BLEEDING AROUND THE THROAT. THE PATIENT WAS ON ANTIBIOTICS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Sore Throat; Unspecified Infection

  MAUDE report 17051577 ↗
• MalfunctionMar 6, 2023Labelling, Instructions for Use or Training Problem; Component Missing; Labelling, Instructions for Use or Training Problem; Component Missing

  ACCORDING TO THE REPORTER, THE PATIENT WAS NOT DOING WELL WITH THE NEWLY PLACED DEVICE AS IT LACKS FENESTRATION, WHICH WAS DIFFERENT FROM WHAT WAS REQUESTED BY THE PHYSICIAN AND DIFFERENT FROM WHAT WAS STATED IN THE PRODUCT LABEL. THE TUBE WAS REPLACED.

  Patient problems: Discomfort; Unintended Extubation

  MAUDE report 16486251 ↗
• MalfunctionAug 22, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE PATIENT FREQUENTLY USES A SPEAKING VALVE MADE BY OTHER MANUFACTURER WITH THE FLEX TRACH TUBES. SOMETIMES THE SPEAKING VALVE FITS CORRECTLY ONTO THE 15MM CONNECTOR, AND SOMETIMES IT DOES NOT SECURE AND SLIDES OFF VERY EASILY. RECANNULATION WAS NOT REQUIRED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265422 ↗
• MalfunctionAug 10, 2022Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, THE WHITE CAP OF THE DEVICE WOULD NOT STAY ON THE 15MM CONNECTOR AND THE PATIENT STATED COULD NOT BREATHE.

  Patient problems: Dyspnea

  MAUDE report 15202209 ↗
• MalfunctionJul 27, 2022Connection Problem; Human-Device Interface Problem; Connection Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CAPS DID NOT SECURELY FIT ON THE TRACH TUBE. THERE WAS LITTLE TO NO RESISTANCE. IT SEEMED TO WORK WITH NO INNER CANNULA IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112597 ↗
• MalfunctionJul 20, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS LEAKING. THE PATIENT HAD DIFFICULTY TALKING WITH THE FINGER ON THE STOMA. THE PATIENT'S FINGER OXIMETER READING WAS 97%. A NEW DEVICE WAS PLACED. THE PATIENT HAD A PERMANENT TRACHEOSTOMY.

  Patient problems: Unintended Extubation

  MAUDE report 15070849 ↗
• MalfunctionMay 18, 2022Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT DID A TRACH CHANGE ON HERSELF WITH THE NEW STYLE, INSTALLATION WAS FINE BUT SHE COULD IMMEDIATELY TELL THE CHANGES WERE NOT BENEFICIAL TO HER. SHE NOTED THAT IT WAS MAKING HER ALREADY CHALLENGED LIFE, WORSE. SHE CANNOT BREATH AS WELL, SHE'S A LOUDER BREATHER NOW. SHE CANNOT SPEAK AS WELL WITH FINGER OCCLUSION AS THE DUCK BILL TIP DOES NOT ALLOW HER TO GET A GOOD SEAL WITH HER FINGER TIP. IT WAS NOW EXHAUSTING TO CARRY ON A CONVERSATION WHEREAS PREVIOUSLY TALKING WAS NOT A BIG ISSUE FOR HER. SECRETIONS WERE ACTIVE, AND THE DUCK BILL TIP MADE IT DIFFICULT TO KEEP THE TIP CLEAN. WHEN SHE REMOVES THE INNER CANNULA TO CLEAN WITH WATER (OFTEN WITH HYDROGEN PEROXIDE TOO) AND A (B)(6) OR PIPE CLEANER, SHE COULD NOT SEE IF SHE HAVE CLEANED EVERYTHING OUT NOW THAT THE INNER TUBE IS OPAQUE AND NOT CLEAR LIKE IT USED TO BE. SHE REMOVED THE DEVICE ON THE SECOND DAY AND PLACED THE OLD STYLE INTO HER STOMA AND IMMEDIATELY FELT A HUGE RELIEF.

  Patient problems: Dyspnea; Unintended Extubation

  MAUDE report 14432387 ↗
• InjuryApr 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS TRANSITIONED FROM 6CFS TRACHEOSTOMY TUBE TO 6UN75R TRACHEAOSTOMY TUBE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED MORE UPPER AIRWAY SYMPTOMS SUCH AS INCREASED COUGHING, DIMINISHED ABILITY TO SPEAK, AND MORE UPPER AIRWAY SECRETIONS. A SCOPE WAS PERFORMED DURING PATIENT'S FOLLOW UP AND IT WAS NOTED THAT THERE WAS VOCAL CHORD IRRITATION AND INFLAMMATION. THE DEVICE WAS REMOVED AND WAS REPLACED WITH 6CFS.

  Patient problems: Cough; Hypersensitivity/Allergic reaction; Respiratory Failure; Unintended Extubation

  MAUDE report 14225117 ↗
• MalfunctionDec 6, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT COULD NOT TOLERATE A SPEAKING VALVE AND RELIES ON FINGER OCCLUSION FOR COMMUNICATION BUT THE PATIENT WAS UNABLE TO PHONATE THE DEVICE BECAUSE OF THE NEW DESIGN OF THE INNER CANNULA. THE LITTLE NOBS PREVENT A GOOD SEAL UPON FINGER OCCLUSION, CAUSING AIR ESCAPE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 12933809 ↗
• MalfunctionOct 5, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE NEW TRACHES WERE FLEXIBLE, CLEAR, WITH A TAPERGUARD CUFF INSTEAD OF BARREL SHAPE CUFF, AND THE 15MM CONNECTOR WAS NOW ATTACHED TO THE FLANGE, NOT THE INNER CANNULA. THE TUMORS USUALLY BEING DEALT WITH COULD NOT HAVE FLEXIBLE MATERIALS AND ARE NOT APPLICABLE FOR PATIENTS WITH CHRONIC TRACHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576589 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2025 · Feb 26, 2025 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R