Optiflux® Ultra 0500416ERecalls & reported problems
Fresenius Medical Care Holdings, Inc. · F160 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.4 m2 / Ebeam / Single Use / 77 mL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840861100187), received between Oct 5, 2017 and Jun 30, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REGISTERED NURSE (RN) REPORTED AN INTERNAL DIALYZER BLOOD LEAK THAT OCCURRED IMMEDIATELY IN A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT OF THE DIALYZER. THE MACHINE, A FRESENIUS 2008K2 MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A BLOOD LEAK TEST STRIP WAS USED AND TESTED POSITIVE. NO VISIBLE DAMAGE WAS OBSERVED ON THE DIALYZER. AFTER THE MACHINE ALARMED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 50 ML. THE RN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED TREATMENT AFTER BEING RESETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE WAS REPORTEDLY NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17243959 ↗MalfunctionOct 5, 2017Fluid/Blood Leak; Fluid/Blood Leak
A HEMODIALYSIS CLINIC REPORTED ONCE HEMODIALYSIS (HD) TREATMENT WAS STARTED THERE WAS BLOOD VISIBLE IN THE DIALYSATE LINE AS WELL AS A BLOOD LEAK ALARM. THE BLOOD PUMP WAS STOPPED, AND BLOOD WAS NOT RETURNED TO THE PATIENT. THE PATIENT WAS STABLE AND COMPLETED TREATMENT ON ANOTHER MACHINE. THERE WAS NO INJURY TO PATIENT. THE MACHINE WAS BLEACHED TWICE AND TESTED NEGATIVE FOR BLOOD AT THE DIALYSATE LINE AND THE DRAIN LINE. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6915969 ↗
Other Dialyzer, high permeability with or without sealed dialysate system devices
- Optiflux® 0500318EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall6 deaths2,849 reports
- 2008® Series Hemodialysis Machines 190713Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls37 deaths893 reports
- 2008T BlueStar Hemodialysis Machine 191126Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system5 recalls10 deaths441 reports
- 2008® Series Hemodialysis Machines 190766Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls15 deaths370 reports
- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
- 2008® Series Hemodialysis Machines 190610Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall15 deaths335 reports
- Optiflux® 0500320EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system2 recalls242 reports
- REVACLEAR 300Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls125 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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