HUDSON RCI IPN044386Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04026704348145), received between Feb 9, 2022 and Oct 24, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT "THE USER WAS UNABLE TO CONNECT THE OXYGEN PORT OF THE TRACH-VENT TO THE TRACHEOSTOMY TUBE DURING USE. THEREFORE, A NEW UNIT WAS USED INSTEAD. NO INJURY TO THE PATIENT WAS REPORTED". ADDITIONAL INFORMATION STATES THAT "THE ISSUE OCCURRED DURING THE PROCEDURE, BUT BEFORE USE ON THE PATIENT. THE USER WAS UNABLE TO CONNECT THE TRACH-VENT TO THE TUBE, SO HE/SHE DID NOT USE IT ON THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524909 ↗
• MalfunctionJul 13, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE "FILTERS ON EITHER SIDE OF THE ARTIFICIAL NOSES FOR TRACHEOSTOMY PATIENTS WERE FULL WITH SECRETIONS AND FELL OFF. WHEN PATIENTS COUGH, THE FILTERS ALSO FALL DOWN". AS A RESULT, THE DEVICE WAS CHANGED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321200 ↗
• MalfunctionMar 6, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  REPORTED ISSUE: TRACH VENT HME DOES NOT COME OF THE CANNULA. CANNULA CHANGE WAS PERFORMED. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16489717 ↗
• MalfunctionDec 6, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE TRAC VENT'S CONNECTOR DOES NOT FIT WELL TO THE TRACHEOSTOMY TUBE. DUE TO THIS IT IS HARD TO CONNECT AND TO DISCONNECT THE TRAC VENT FROM THE TRACHEOSTOMY TUBE. NO INJURY REPORTED AND A NEW TRACH VENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927813 ↗
• MalfunctionDec 6, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE TRAC VENT'S CONNECTOR DOES NOT FIT WELL TO THE TRACHEOSTOMY TUBE. DUE TO THIS IT IS HARD TO CONNECT AND TO DISCONNECT THE TRAC VENT FROM THE TRACHEOSTOMY TUBE. NO INJURY REPORTED AND A NEW TRACH VENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927705 ↗
• MalfunctionDec 6, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE TRAC VENT'S CONNECTOR DOES NOT FIT WELL TO THE TRACHEOSTOMY TUBE. DUE TO THIS IT IS HARD TO CONNECT AND TO DISCONNECT THE TRAC VENT FROM THE TRACHEOSTOMY TUBE. NO INJURY REPORTED AND A NEW TRACH VENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926628 ↗
• MalfunctionFeb 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED: THE "PATIENT EXPERIENCED THROAT SWELLING AND RED MARK AFTER USING PRODUCT". DEVICE REMOVED AND A DIFFERENT DEVICE WAS USED. ADDITIONAL INFORMATION STATED THAT PATIENT HAD SMALL ABRASION FROM THE DEVICE. POLYSPORIN TOPICAL TREATMENT USED. NO SERIOUS OR PERMANENT INJURY REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13497529 ↗