Shiley 6UN75HRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 20884521176253), received between Jan 16, 2019 and Mar 24, 2025 — classified as 16 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (28 reports).

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

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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE USE OF A TRACHEOSTOMY, THE INNER CANNULA DID NOT RELEASE FROM THE TRACH AS EXPECTED WHEN THE TIP WAS SQUEEZED. THE CAREGIVER NEEDED TO USE A TOOL TO APPLY THE AMOUNT OF PRESSURE NEEDED TO RELEASE THE INNER CANNULA. BOTH THE PATIENT AND CAREGIVER WERE UNABLE TO REMOVE THE INNER CANNULA WITHOUT USING A TOOL. THERE WAS NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677279 ↗
• MalfunctionOct 11, 2024Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE RED CAP ON THE TRACHEOSTOMY TUBE DOES NOT CLIP OR SCREW ONTO THE TRACH. THEREFORE, EVERY TIME THE PATIENT COUGHS THE RED CAP FLIES ACROSS THE ROOM. HAD RESORTED TO USING SUPER GLUE TO KEEP THE CAP ON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427919 ↗
• MalfunctionAug 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TRACHEOSTOMY CANNULA FAILED TO WORK PROPERLY DURING INTUBATION. THE TUBE WAS REMOVED, AND ANOTHER TUBE WAS USED WITH NO HARM.

  Patient problems: Unintended Extubation

  MAUDE report 19960752 ↗
• InjuryJun 3, 2024Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, DURING USE, THE PLATE OF THE TRACHEOSTOMY CANNULA TURNED BLACK FOR THE FOURTH TIME. THE PATIENT NEEDED TO BE PLACED ON ANTIBIOTICS AS A PRECAUTION AGAINST INFECTION. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19454789 ↗
• InjuryJun 3, 2024Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, DURING USE, THE PLATE OF THE TRACHEOSTOMY CANNULA TURNED BLACK FOR THE FOURTH TIME. THE PATIENT NEEDED TO BE PLACED ON ANTIBIOTICS AS A PRECAUTION AGAINST INFECTION. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19454774 ↗
• InjuryJun 3, 2024Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, DURING USE, THE PLATE OF THE TRACHEOSTOMY CANNULA TURNED BLACK FOR THE FOURTH TIME. THE PATIENT NEEDED TO BE PLACED ON ANTIBIOTICS AS A PRECAUTION AGAINST INFECTION. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19454499 ↗
• InjuryJun 3, 2024Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, DURING USE, THE PLATE OF THE TRACHEOSTOMY CANNULA TURNED BLACK FOR THE FOURTH TIME. THE PATIENT NEEDED TO BE PLACED ON ANTIBIOTICS AS A PRECAUTION AGAINST INFECTION. THE REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19454197 ↗
• MalfunctionApr 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD ISSUES DURING PATIENT USE. PATIENT HAD VERY SORE THROAT AND SOME BLEEDING.

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

  MAUDE report 19073048 ↗
• MalfunctionApr 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE HAD ISSUES DURING PATIENT USE. PATIENT HAD VERY SORE THROAT AND SOME BLEEDING.

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

  MAUDE report 19070324 ↗
• InjuryJan 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS UNABLE TO USE THE SPEAKING VALVE WHILE AN INNER CANNULA WAS INSERTED. WITH THE NEW STYLE, THE PATIENT NEEDS TO BLOCK WITH A FINGER INSTEAD OF THE SPEAKING VALVE BECAUSE IT WOULD NOT FIT. IT WAS STATED THAT THE PATIENT BLAMES CATCHING COVID ON NEEDING TO TOUCH THE "IC," WHICH WAS UNSANITARY. THE PATIENT WAS INFECTED.

  Patient problems: Bacterial Infection; Viral Infection

  MAUDE report 18467627 ↗
• InjuryJan 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS UNABLE TO USE THE SPEAKING VALVE WHILE AN INNER CANNULA WAS INSERTED. WITH THE NEW STYLE, THE PATIENT NEEDS TO BLOCK WITH A FINGER INSTEAD OF THE SPEAKING VALVE BECAUSE IT WOULD NOT FIT. IT WAS STATED THAT THE PATIENT BLAMES CATCHING COVID ON NEEDING TO TOUCH THE "IC," WHICH WAS UNSANITARY. THE PATIENT WAS INFECTED.

  Patient problems: Bacterial Infection; Viral Infection

  MAUDE report 18467576 ↗
• MalfunctionJan 3, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE NEW DESIGN OF THE TRACHEOSTOMY TUBE'S INNER CANNULA WAS LEAKING AT THE TOP OF THE TRACH. THE PATIENT TRIED SEVERAL NEW-DESIGN INNER CANNULAS, AND ALL LEAKED. THERE WAS NO PATIENT HARM, ONLY DISCOMFORT FROM THE LEAK. IT WAS STATED THAT THE OLD DESIGN OF THE TRACH DID NOT LEAK; THE PROBLEM WAS WITH THE DESIGN OR INTERFACE, NOT A PRODUCT MALFUNCTION.

  Patient problems: Discomfort

  MAUDE report 18439553 ↗
• MalfunctionOct 26, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CAP WAS VERY LOOSE WHEN APPLIED. THE PATIENT EASILY COUGHED THE CAP OFF. THE TUBE WAS CHANGED.

  Patient problems: Unintended Extubation

  MAUDE report 18012704 ↗
• InjuryJul 10, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT HAD A CONTINUOUS DISCOMFORT SINCE THE LAST REPLACEMENT OF THE TRACHEOSTOMY TUBE. THE TUBE WAS A RECALLED DEVICE BUT THE PATIENT WAS NOT INFORMED BY THE ATTENDING ENT (EAR, NOSE AND THROAT) DOCTOR.

  Patient problems: Discomfort

  MAUDE report 17288298 ↗
• MalfunctionJun 16, 2023Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE HAD TROUBLE BEING CAPPED. THE CAP WAS NOT SNUG AFTER OPENING A BUNCH OF CAPS, GOT ONE TO FIT HOWEVER, THE CAPS THAT DID NOT WORK FIT THE TRAINING TRACH'S WELL WHICH WAS NOTED A KNOWN ISSUE WITH THE CAP'S. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE 15MM CONNECTOR FROM TUBE USING CAP SAMPLE DID NOT FIT PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142852 ↗
• MalfunctionMay 25, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS POPPING OFF DURING THE DECANNULATION PROCEDURE SWITCHING TO THE CUFFLESS TRACH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004652 ↗
• InjuryApr 7, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CAP DISLODGED TOO EASILY WHEN PATIENT COUGH DURING DECANNULATION TRIAL. IT WAS FOUND OUT THAT THE CAP STAYED IN PLACE IF THE INNER CANNULA WAS NOT INSERTED. TO BE ABLE TO DECANNULATE TRACHEOSTOMY THE PATIENT, STARTED REMOVING THE INNER CANNULA ROUTINELY FOR TRACH DECANNULATION.

  Patient problems: Unintended Extubation

  MAUDE report 16702811 ↗
• MalfunctionMar 30, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO PLUG. THE LOT WAS TOO NARROW. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 16645738 ↗
• MalfunctionMar 28, 2023Disconnection; Connection Problem; Material Integrity Problem; Disconnection; Connection Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE TRACH "POPPED OFF" THE VENTILATOR AND CAPS WHILE IN USE. WHEN THE INNER CANNULA WAS REMOVED, THE VENTILATOR TUBING AND CAP FIT NORMALLY. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16632238 ↗
• MalfunctionMar 28, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE "POPPED OFF" THE VENTILATOR AND CAPS WHILE IN USE. WHEN THE INNER CANNULA WAS TRIED TO REMOVE THE VENTILATOR TUBING AND CAP FIT NORMALLY. THE TUBE WAS REPLACED.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 16632157 ↗
• MalfunctionMar 27, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE CAP WAS NOT FITTING CORRECTLY WITH THE DEVICE, SAME WITH VENT TUBING AND SPEAKING VALVES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618658 ↗
• MalfunctionMar 24, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE CAP OF THE DEVICE WAS DISLODGING TOO EASILY OR COUGHING OFF WHEN AN ATTEMPTED DECANNULATION TRIAL WAS MADE, WHICH DELAYED THE PATIENT'S DISCHARGE. IT WAS FOUND THAT THE CAP WOULD STAY IN PLACE IF THE INNER CANNULA WAS ABSENT. IN ORDER TO DECANNULATE PATIENTS, THE INNER CANNULA WAS ROUTINELY REMOVED, AND THE MANAGEMENT CONTINUED UNTIL THE DEVICE WAS TRANSITIONED TO A NEW MODEL OF TRACH TUBE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Unintended Extubation

  MAUDE report 16615110 ↗
• InjuryMar 24, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CAP DISLODGED TOO EASILY WHEN THE PATIENT COUGHED DURING THE DECANNULATION TRIAL. IT WAS FOUND OUT THAT THE CAP STAYED IN PLACE IF THE INNER CANNULA WAS NOT INSERTED. TO BE ABLE TO DECANNULATE THE TRACHEOSTOMY, THE PATIENT STARTED REMOVING THE INNER CANNULA ROUTINELY FOR TRACH DECANNULATION. IT WAS REPORTED THAT THE PATIENT ENDED UP HAVING A DISCHARGE DELAY RELATED TO A PROLONGED CAPPING TRIAL.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 16612179 ↗
• MalfunctionMar 24, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE CAP OF THE DEVICE WAS DISLODGING TOO EASILY OR COUGHING OFF WHEN AN ATTEMPTED DECANNULATION TRIAL WAS MADE, WHICH DELAYED THE PATIENT'S DISCHARGE. IT WAS FOUND THAT THE CAP WOULD STAY IN PLACE IF THE INNER CANNULA WAS ABSENT. IN ORDER TO DECANNULATE PATIENTS, THE INNER CANNULA WAS ROUTINELY REMOVED, AND THE MANAGEMENT CONTINUED UNTIL THE DEVICE WAS TRANSITIONED TO A NEW MODEL OF TRACH TUBE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Unintended Extubation

  MAUDE report 16611613 ↗
• MalfunctionMar 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE "DIMPLES" AT THE TOP AND BOTTOM OF THE DEVICE CAUSED SEVERE RUBBING ON THE PATIENT'S NECK ESPECIALLY AFTER SHAVING.

  Patient problems: Inflammation

  MAUDE report 16482083 ↗