Polyflux 140HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07332414037925), received between Jun 18, 2018 and Oct 18, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE HEADER OF A POLYFLUX 140H DURING HEMODIALYSIS THERAPY. THE DEVICE WAS REPLACED TO CONTINUE TREATMENT. 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 20482970 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL LEAK WAS OBSERVED FROM THE 'UPPER REGION OF THE FILTER' OF A POLYFLUX 140H DURING THE START OF THERAPY. THE FILTER WAS IMMEDIATELY REPLACED WITH A NEW ONE TO CONTINUE TREATMENT. 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 18610340 ↗
• MalfunctionAug 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH A POLYFLUX 140H, AN EXTERNAL FLUID LEAK AT THE CAP WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141858 ↗
• MalfunctionMay 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A POLYFLUX 140 H, A LEAKING DIALYZER WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346119 ↗
• MalfunctionJul 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH (ONE 1) UNIT OF POLYFLUX 140H, AN EXTERNAL DIALYSATE LEAK WAS OBSERVED AT THE TOP, UNDER THE DIALYZER LID. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216942 ↗
• MalfunctionJul 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH TWO (2) UNITS OF POLYFLUX 140H, AN EXTERNAL DIALYSATE LEAK WAS OBSERVED AT THE TOP, UNDER THE DIALYZER LID. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210407 ↗
• MalfunctionJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH ONE (1) UNIT OF POLYFLUX 140H, AN EXTERNAL FLUID LEAK WAS OBSERVED AT THE CAP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129994 ↗
• MalfunctionJun 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED ON SIX UNITS OF POLYFLUX 140H DURING TREATMENT WITH 6 PATIENTS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033211 ↗
• MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED AT THE CONNECTION OF TWO UNITS OF POLYFLUX 140H DURING PATIENT TREATMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843560 ↗
• MalfunctionApr 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A POLYFLUX 140 H, A FLUID LEAK WAS OBSERVED FROM THE FILTER HOUSING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694255 ↗
• MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE HOUR AFTER STARTING TREATMENT WITH A POLYFLUX 140H DIALYZER, AN EXTERNAL FLUID LEAKAGE WAS OBSERVED FROM THE ARTERIAL END OF THE DIALYZER. IT WAS REPORTED THE FILTER CONNECTORS WERE ¿ADJUSTED¿ AND WELL CONNECTED, HOWEVER, THE LEAKAGE CONTINUED. TOTAL RESTITUTION OF BLOOD VOLUME TO THE PATIENT WAS PERFORMED AND NO BLOOD LEAK WAS OBSERVED. TREATMENT WAS ENDED. THE DIALYZER WAS CHANGED WITH ANOTHER POLYFLUX 140H AND THERAPY WAS CONTINUED WITH NO ISSUES NOTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10952308 ↗
• MalfunctionNov 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER 15 MINUTES OF STARTING THERAPY WITH A POLYFLUX 140H DIALYZER, REPORTED AS THERANOVA, AN EXTERNAL FLUID LEAK WAS OBSERVED ¿FROM THE VENOUS END OF THE DIALYZER¿. THE EXTRACORPOREAL CIRCUIT RESTITUTION WAS PERFORMED. TREATMENT WAS DISCONTINUED, AND THE DIALYZER WAS EXCHANGED AND USED WITHOUT COMPLICATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900674 ↗
• MalfunctionSep 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A POLYFLUX 140H SET, AN EXTERNAL DIALYSIS SOLUTION LEAKAGE WAS OBSERVED ¿FROM THE LOWER PART¿ OF THE DIALYZER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088845 ↗
• MalfunctionJun 18, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A POLYFLUX 140 H SET LEAKED AT THE HOUSING DURING PATIENT TREATMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611441 ↗