Hemoflow™ 0500145ARecalls & reported problems
Fresenius Medical Care Holdings, Inc. · F6 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL · Class 2
All models of Hemoflow (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861100033), received between May 25, 2018 and May 25, 2018 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY TEN MINUTES INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK DUE TO A RUPTURED MEMBRANE IN THE DIALYZER. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7545564 ↗
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 21LGambro Dialysatoren GmbH · DIALYZER, CAPILLARY, HOLLOW FIBER5 reports
- Polyflux 14LGambro Dialysatoren GmbH · DIALYZER, CAPILLARY, HOLLOW FIBER2 reports
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 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page