HUDSON RCI IPN048960Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704617088), received between Aug 23, 2022 and Oct 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606798 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT: "THE DOCTOR FOUND BALLOON BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277787 ↗