Polyflux 21LRecalls & reported problems
Gambro Dialysatoren GmbH · The Polyflux 21L is intended for use in haemodialysis for the treatment of chronic or acute renal failure · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07332414048181), received between Nov 2, 2020 and Nov 22, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Crack3
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗MalfunctionMar 7, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT DURING PREPARATION WITH TWO UNITS OF POLYFLUX 21 L, A CRACK AND LEAKING SOLUTION "ON TOP" WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16498279 ↗MalfunctionNov 2, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED DURING TREATMENT WITH A POLYFLUX21L DIALYZER, A BLOOD LEAK AT THE VENOUS SIDE WAS OBSERVED. THE PATIENT WAS IMMEDIATELY DISCONNECTED. BLOOD LOSS WAS REPORTED TO BE "ONLY A FEW DROPS". 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 10769772 ↗
Other DIALYZER, CAPILLARY, HOLLOW FIBER devices
- Optiflux® 0500316EFresenius Medical Care Holdings, Inc. · DIALYZER, CAPILLARY, HOLLOW FIBER2 recalls7 deaths2,282 reports
- Polyflux 170HGambro Dialysatoren GmbH · DIALYZER, CAPILLARY, HOLLOW FIBER23 reports
- Polyflux 140HGambro Dialysatoren GmbH · DIALYZER, CAPILLARY, HOLLOW FIBER14 reports
- Hemoflow™ 0520165AFresenius Medical Care Holdings, Inc. · DIALYZER, CAPILLARY, HOLLOW FIBER11 reports
- Hemoflow™ 0520161AFresenius Medical Care Holdings, Inc. · DIALYZER, CAPILLARY, HOLLOW FIBER10 reports
- Hemoflow™ 0500164AFresenius Medical Care Holdings, Inc. · DIALYZER, CAPILLARY, HOLLOW FIBER7 reports
- Polyflux 14LGambro Dialysatoren GmbH · DIALYZER, CAPILLARY, HOLLOW FIBER2 reports
- Hemoflow™ 0500145AFresenius Medical Care Holdings, Inc. · DIALYZER, CAPILLARY, HOLLOW FIBER1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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