HUDSON RCI IPN044066Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704597451), received between Jan 25, 2021 and Jan 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE "2411-03 INFANT HIGH FLOW CANNULA WAS FOUND TO BE PULLING APART NEAR THE PRONGS". NO MEDICAL INTERVENTION REQUIRED. NO PATIENT INJURY OR DESATURATION REPORTED. USER REPLACED DEVICE WITH A NEW DEVICE. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11226946 ↗