Shiley CAPRecalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 60884522005352), received between May 3, 2021 and Oct 11, 2024 — classified as 2 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (70 reports).

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 90 reports, in the reporter's own words as published by the FDA.

• 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 20434430 ↗
• MalfunctionJul 19, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE POPPED OUT OF THE TRACH WHEN THE PATIENT COUGHED. THE CORK WAS REPLACED WITH ANOTHER ONE, AND IT STAYED ON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17354114 ↗
• MalfunctionApr 21, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE WHITE CAP WAS LOOSE ON TRACH AS THE PATIENT WOULD COUGH IT OUT DURING USE. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16785268 ↗
• MalfunctionApr 13, 2023Disconnection; Connection Problem; Disconnection; 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 16737835 ↗
• MalfunctionApr 10, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS POPPING OFF. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709854 ↗
• 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 16702821 ↗
• InjuryApr 3, 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 16666726 ↗
• MalfunctionFeb 28, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT SECURELY FITTED ON THE 15MM CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455689 ↗
• MalfunctionFeb 22, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT WOULD NOT FIT ON TRACH DESPITE SEVERAL ATTEMPTS AND DIFFERENT CAPS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16417679 ↗
• MalfunctionFeb 20, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD BECOME DETACHED FROM THE TRACHEOSTOMY TUBE AND HAD FALLEN OFF. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404143 ↗
• MalfunctionJan 10, 2023Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE PATIENT WAS UNDERGOING A CAPPING TRIAL AND THE FACILITY WAS UNABLE TO CAP THE TRACH. THE CAP COULD NOT STAY ON THE TRACHEOSTOMY TUBE, SLIGHTEST COUGH WILL POP IT OFF. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131847 ↗
• MalfunctionJan 6, 2023Connection Problem; Connection Problem

  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 16117659 ↗
• MalfunctionJan 6, 2023Connection Problem; Connection Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117643 ↗
• MalfunctionJan 6, 2023Connection Problem; Connection Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117605 ↗
• MalfunctionJan 6, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS NOT FITTED ON REUSABLE TRACH, HAD DIMENSIONAL ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16116209 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009434 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009352 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16009141 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009033 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008756 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008681 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008441 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008275 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008233 ↗
• MalfunctionDec 19, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE AT THE END OF THE TRACH WAS VERY LOOSE AND FLIES OFF WHEN THE PATIENT COUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008225 ↗