Polyflux 17LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332414036416), received between Apr 20, 2023 and Apr 20, 2023 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY TWO HOURS AFTER THE START OF A HEMODIALYSIS THERAPY, WITH A POLYFLUX 17 L DIALYZER, THE PATIENT EXPERIENCED SYMPTOMS INCLUDING HYPERTENSION, STOMACHACHE, GENERAL UNWELLNESS, SKIN REDNESS, DARK URINE, HICCUPS, AND HEARTBURN. THE PATIENT REQUIRED MEDICAL INTERVENTION IN THE HOSPITAL FOR HYDRATION, RED BLOOD CELL TRANSFUSION, AND MORE EFFECTIVE DIALYSIS. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY THREE DAYS AND THEN DISCHARGED. DIALYSIS THERAPY REMAINS ONGOING. THE PATIENT'S HEMOGLOBIN LEVEL IS STILL LOW AND SKIN COLOR RETURNED TO NORMAL. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Abdominal Pain; Erythema; Heartburn/Indigestion; Hemolysis; Hiccups; High Blood Pressure/ Hypertension; Malaise

  MAUDE report 16778120 ↗