HUDSON RCI IPN044790Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026704397310), received between May 24, 2024 and Jul 25, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2025, IT WAS DISCOVERED THAT THE BALLOON TUBE WAS LEAKING AT THE SIDE OF THE CONNECTION TO THE CANNULA WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607374 ↗
• MalfunctionSep 23, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: "THE CUFF DIDN'T INFLATE DURING THE INFLATION TEST BEFORE USE. THEREFORE, A NEW KIT WAS USED INSTEAD. THERE WAS NO PATIENT INVOLVEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277193 ↗
• MalfunctionJul 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE TRACHEAL TUBE WAS BENT AND RECOVERED, BUT THE TRACHEA CREATED A NARROWING THAT PREVENTED RECOVERY TO COMPLETE V ENTILATION." THE USER CHANGED TO A NEW SET AND THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19825922 ↗
• MalfunctionJun 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526994 ↗
• MalfunctionMay 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "(B)(6) 2024, THE WIRE IS EXPOSED WHEN USING REINFORCED TRACHEAL INTUBATION AND CANNOT WITHSTAND THE PATIENT'S ORAL CLOSURE PRESSURE UNDER GENERAL ANESTHESIA, RESULTING IN TRACHEAL OBSTRUCTION." ANOTHER DEVICE WAS USED. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390482 ↗