PolyfluxRecalls & reported problems across all models
Gambro Dialysatoren GmbH · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 7 models of Polyflux by Gambro Dialysatoren GmbH in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Dec 31, 2017 and Mar 19, 2026 — classified as 8 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Polyflux problems
Device problems
- Fluid/Blood Leak32
- Adverse Event Without Identified Device or Use Problem9
- Crack3
- Leak/Splash3
- Device Contamination with Chemical or Other Material2
- Break1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient11
- Chills4
- Alteration In Body Temperature3
- Nausea3
- Dyspnea2
- Hypersensitivity/Allergic reaction2
- Malaise2
Polyflux models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Polyflux 170HDIALYZER, CAPILLARY, HOLLOW FIBER23 reports
- Polyflux 140HDIALYZER, CAPILLARY, HOLLOW FIBER14 reports
- Polyflux 21LDIALYZER, CAPILLARY, HOLLOW FIBER5 reports
- Polyflux 14LDIALYZER, CAPILLARY, HOLLOW FIBER2 reports
- Polyflux 6HDialyzer, high permeability with or without sealed dialysate system1 report
- Polyflux 17LDIALYZER, CAPILLARY, HOLLOW FIBER1 report
- Polyflux 210HDIALYZER, CAPILLARY, HOLLOW FIBER1 report
Recent Polyflux adverse event reports
The 15 most recent reports across all models, 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 ↗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 22, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A "CRACK IN THE CAPILLARY" OF A POLYFLUX 21L DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759360 ↗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 ↗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 ↗MalfunctionAug 28, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK AND A CRACK WAS OBSERVED "IN THE CAPILLARY" OF A POLYFLUX 21L DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20087235 ↗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 ↗MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE "CASING AND HEAD PART" OF A POLYFLUX 6H DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970881 ↗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 ↗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 ↗MalfunctionSep 27, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING AT THE TOP OF THE DIALYZER OF A POLYFLUX 21 L SET DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17826125 ↗
Other Gambro Dialysatoren GmbH products
All Gambro Dialysatoren GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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