HUDSON RCI IPN048951Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704616999), received between Aug 6, 2021 and Jan 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 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.

• MalfunctionJan 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF DID NOT INFLATE WELL COMPARED TO BEFORE. THE ISSUE OCCURRED AT PRETEST BEFORE USE ON A PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384930 ↗
• MalfunctionJan 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF DIDN'T INFLATE WELL COMPARED TO BEFORE. THE ISSUE OCCURRED AT PRETEST BEFORE USE ON A PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384809 ↗
• MalfunctionAug 6, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE AIR LEAKED FROM THE CUFF BEFORE USE ON A PATIENT. THEREFORE, A NEW UNIT WAS OPENED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288089 ↗