Polyflux 170HRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07332414037932), received between Dec 31, 2017 and Jul 22, 2025 — classified as 7 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "BLOOD WAS GOING INTO THE DIALYSATE" OF THREE (3) POLYFLUX 170 DIALYZERS 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 22569868 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THREE (3) POLYFLUX 170 DIALYZERS 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 22546765 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A BLOOD LEAK WAS OBSERVED DURING HEMODIALYSIS THERAPY FROM UNSPECIFIED LOCATIONS OF THREE (3) POLYFLUX 170 DIALYZERS. THE DEVICES WERE USED FOR ONE (1) PATIENT, "WITH THE SAME RESULT". THE VOLUME OF BLOOD LOSS OR WHETHER BLOOD WAS RETURNED WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541035 ↗
• MalfunctionNov 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A POLYFLUX 170H WAS "LEAKING AT THE EXTREMITY" DURING AN UNSPECIFIED PROCESS STEP. 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 20634431 ↗
• MalfunctionJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) INTERNAL BLOOD LEAKS WERE OBSERVED FROM TWO (2) POLYFLUX 170 H DIALYZERS DURING HEMODIALYSIS THERAPY. THE BLOOD WAS NOT RETURNED TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469509 ↗
• MalfunctionMay 20, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWO (2) INTERNAL BLOOD LEAKS OCCURRED ON ONE (1) PATIENT DURING USE OF A POLYFLUX 170H FOR HEMODIALYSIS THERAPY. THE REPORTED BLOOD LOSS WAS 300ML WITH A DROP OF 1.5 MMOL/L IN HEMOGLOBIN. THE EXTRACORPOREAL CIRCUIT WAS REPLACED TO COMPLETE TREATMENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353302 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 25 MINUTES AFTER STARTING TREATMENT WITH A POLYFLUX, THE PATIENT EXPERIENCED CHEST TIGHTNESS, SWEATING, NAUSEA, AND DISCOMFORT. THE PATIENT¿S BLOOD PRESSURE WAS REPORTED AS 85/49MMHG. MEDICAL INTERVENTION CONSISTED OF DEXAMETHASONE 5 MG, 200 ML OF NORMAL SALINE, AND 40ML OF 50% GLUCOSE. IT WAS REPORTED THAT SWEATING AND NAUSEA SYMPTOMS WERE RELIEVED; HOWEVER, THE CHEST TIGHTNESS DID NOT SUBSIDE UNTIL THE PATIENT WAS DISCONNECTED FROM THE TREATMENT, AND GIVEN OXYGEN. ACCORDING TO THE REPORTER, THE PATIENT "LEFT THE HOSPITAL" ONE HOUR LATER AFTER THE SYMPTOMS HAD SUBSIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Diaphoresis; Discomfort; Hypersensitivity/Allergic reaction; Nausea

  MAUDE report 19088833 ↗
• MalfunctionOct 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM AN UNSPECIFIED LOCATION OF THE POLYFLUX 170H SET DURING USE. THE AMOUNT OF BLOOD LOSS WAS NOT INDICATED. 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 18013432 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING HEMODIALYSIS THERAPY WITH A POLYFLUX 170H SET, THE PATIENT EXPERIENCED NAUSEA AND EMESIS. THE PATIENT WAS TREATED WITH INTRAVENOUS DEXAMETHASONE SODIUM PHOSPHATE (5MG) AND OXYGEN THERAPY. THE SYMPTOMS WERE MITIGATED WITHIN THE 10 MINUTES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Nausea; Vomiting

  MAUDE report 17772833 ↗
• MalfunctionOct 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH ONE UNIT OF POLYFLUX 170H, AN EXTERNAL FLUID LEAKAGE WAS NOTED FROM THE DIALYZER HOUSING. 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 15669821 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN 10 MINUTES OF USE WITH ONE UNIT OF A POLYFLUX 170H, THE PATIENT EXPERIENCED CHEST TIGHTNESS, SHORTNESS OF BREATH, VOMITING AND DECREASED BLOOD PRESSURE. THE PATIENT WAS GIVEN OXYGEN (4L/MIN), DEXAMETHASONE (10MG) AND HIGH GLUCOSE (40ML) FOR THE EVENTS. THE DIALYZER WAS REPLACED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 14348681 ↗
• MalfunctionJun 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PRIMING OF A POLYFLUX 170 H DIALYZER, AN EXTERNAL FLUID LEAK WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050118 ↗
• MalfunctionFeb 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UPON STARTING TREATMENT WITH A POLYFLUX 170H, AN EXTERNAL DIALYSATE LEAK WAS OBSERVED AT THE HEADER. 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 11331340 ↗
• MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CRACK AND A LEAK WAS OBSERVED ON TWO UNITS OF POLYFLUX 170H DURING PATIENT USE. BLOOD LOSS OF 100 ML WAS REPORTED. 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 10809669 ↗
• MalfunctionDec 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING PATIENT TREATMENT WITH A POLYFLUX 170H SET, AN EXTERNAL FLUID LEAK WAS OBSERVED. IT WAS REPORTED, TREATMENT WAS STOPPED, AND THE DIALYZER WAS REPLACED. 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 9459250 ↗
• MalfunctionMar 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING PATIENT TREATMENT WITH TWO POLYFLUX 17L, TWO INTERNAL BLOOD LEAK WERE OBSERVED. THE FIRST EVENT OCCURRED 10 MINUTES AFTER STARTING TREATMENT. IT WAS REPORTED THE DIALYZER MEMBRANES/FIBERS WERE FOUND BROKEN ¿INTERNALLY¿. TREATMENT WAS DISCONTINUED. THERAPY WAS RESTARTED WITH A NEW DIALYZER AND 10 MINUTES AFTER STARTING TREATMENT THE MEMBRANES/FIBERS WERE FOUND BROKEN. TREATMENT WAS DISCONTINUED. THERAPY WAS RESTARTED WITH A NEW DIALYZER AND NO ISSUES WERE NOTED. 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 8464714 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 18 PATIENTS USING A POLYFLUX 17H EXPERIENCED CHILLS, HEADACHE, MALAISE AND NAUSEA DURING THERAPY. THE PATIENTS WERE TREATED WITH 100MG OF HYDROCORTISONE INTRAVENOUSLY, 75MG OF DICLOFENAC, 3LT X1MTS OF OXYGEN AND 1G OF VANCOMYCIN WAS ADMINISTERED INTRAVENOUSLY. IT WAS REPORTED THAT THE PATIENTS IMPROVED AFTER TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Chills; Headache; Malaise; Nausea

  MAUDE report 8386194 ↗
• MalfunctionDec 27, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PRIMING OF A POLYFLUX 170H DIALYZER, BLACK PARTICLES WERE OBSERVED INSIDE THE FILTER ¿ON THE BLOOD SIDE OF THE DIALYZER¿. NO PARTICLES WERE OBSERVED IN THE SET. THE SET AND FILTER WERE CHANGED PRIOR TO STARTING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8200674 ↗
• MalfunctionSep 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING SET UP WITH TWO UNITS OF POLYFLUX 170H DIALYZERS, YELLOWISH SPOTS WERE OBSERVED BETWEEN THE FIBERS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7910632 ↗
• MalfunctionAug 27, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT A POLYFLUX 170 H WAS FOUND DEFECTIVE (NOT FURTHER SPECIFIED) DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818001 ↗
• InjuryDec 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY APPROXIMATELY 30 MIN AFTER TREATMENT START THE PATIENT PRESENTED WITH SHIVERING, MUSCLE TENSION AND INCREASED BODY TEMPERATURE WHEN USING A POLYFLUX 170H DIALYZER. THE PATIENT RECEIVED MEDICATION (AVIL, HYDROCORTISONE, PERFALGAN AND SALINE) FOR THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Alteration In Body Temperature; Chills

  MAUDE report 7156317 ↗
• InjuryDec 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY APPROXIMATELY 30 MIN AFTER TREATMENT START THE PATIENT PRESENTED WITH SHIVERING, MUSCLE TENSION AND INCREASED BODY TEMPERATURE WHEN USING A POLYFLUX 170H DIALYZER. THE PATIENT RECEIVED MEDICATION (AVIL, HYDROCORTISONE, PERFALGAN AND SALINE) FOR THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Alteration In Body Temperature; Chills

  MAUDE report 7156316 ↗
• InjuryDec 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY APPROXIMATELY 30 MIN AFTER TREATMENT START THE PATIENT PRESENTED WITH SHIVERING, MUSCLE TENSION AND INCREASED BODY TEMPERATURE WHEN USING A POLYFLUX 170H DIALYZER. THE PATIENT RECEIVED MEDICATION (AVIL, HYDROCORTISONE, PERFALGAN AND SALINE) FOR THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Alteration In Body Temperature; Chills

  MAUDE report 7156315 ↗