Polyflux 14LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07332414036423), received between Sep 10, 2018 and Mar 19, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A POLYFLUX 14 L DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639915 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FIVE MINUTES INTO TREATMENT WITH A POLYFLUX 14L, A PATIENT EXPERIENCED COUGH, CHEST TIGHTNESS AND SHORTNESS OF BREATH. THE TREATMENT WAS DISCONTINUED AND BLOOD WAS RETURNED TO THE PATIENT. THE PATIENT WAS IMMEDIATELY TREATED WITH DEXAMETHASONE INJECTION 5MG INTRAVENOUSLY AND WAS PLACED ON CONTINUOUS LOW FLOW OXYGEN. IT WAS REPORTED THAT SYMPTOMS PERSISTED AND THE PATIENT WAS TREATED WITH AN INTRAVENOUS INJECTION OF DEXAMETHASONE 10MG, 0.9% SODIUM CHLORIDE INJECTION 20ML AND 10% CALCIUM GLUCONATE INJECTION 20ML AND WAS CLOSELY MONITORED. AT THE TIME OF THE REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Chest Tightness/Pressure; Dyspnea

  MAUDE report 7861981 ↗