HUDSON RCI IPN049316Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704630179), received between Apr 5, 2021 and Oct 18, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED "WHEN THE USER ATTEMPTED TO USE THE DEVICE, AIR LEAKED FROM THE MAIN BODY. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12646899 ↗
• MalfunctionOct 5, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "COMPLAINANT STATES THAT WHEN HER MOTHER (AT-HOME PATIENT) ATTEMPTS TO USE THE DEVICE, IT SEEMS AS IF THE AIR WILL NOT PASS THROUGH IT, ALMOST LIKE THERE IS A LEAK OR A CRACK SOMEWHERE ON THE DEVICE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580078 ↗
• MalfunctionApr 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "BALL IS NOT MOVING WHEN PATIENT BREATHES". UNKNOWN PATIENT CONDITION AT TIME OF REPORT. NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11613299 ↗