Optiflux® 0500318ERecalls & reported problems
Fresenius Medical Care Holdings, Inc. · F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / Ebeam / Single Use / 102 mL · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Fresenius Optiflux dialyzer is a blood filter used in hemodialysis treatment. Its 2,847 reports mostly describe blood leaking inside the dialyzer during treatment, and many mention bleeding. The reports include 6 deaths and 147 injuries. Reports in the last 12 months (191) are well below the previous 12 months (556). There is 1 open recall, started in August 2025, over caps that need to be pressed firmly onto the dialyzer to stay secure.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,849
- Deaths reported
- 6
- Injuries reported
- 148
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,849 adverse event reports that list this exact device (DI 00840861100156), received between Dec 30, 2015 and Sep 30, 2026 — classified as 6 deaths, 148 injuries, 2,695 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2,619 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 29, 2025Open, Classified
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Z-0041-2026 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2,619
- Adverse Event Without Identified Device or Use Problem124
- Labelling, Instructions for Use or Training Problem83
- Air Leak6
- Crack6
- Leak/Splash6
- Obstruction of Flow5
- Occlusion Within Device4
Patient problems
- Hemorrhage/Blood Loss/Bleeding1,199
- No Clinical Signs, Symptoms or Conditions793
- No Known Impact Or Consequence To Patient730
- Itching Sensation62
- Hypersensitivity/Allergic reaction37
- Low Blood Pressure/ Hypotension29
- Blood Loss27
- Dyspnea21
Recent adverse event reports
The 25 most recent of 2,849 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50952208 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50952096 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50951907 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypersensitivity/Allergic reaction; Hypoxia; Respiratory Failure
MAUDE report 50951299 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50934857 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50904141 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50899303 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50889998 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50839522 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50839521 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50806310 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
A user facility¿s biomedical technician (BMT) reported that a visible internal dialyzer blood leak occurred five minutes after the initiation of the patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, did not alarm. Blood leak test strips were used and tested negative for the presence of blood. A FME bloodline was not in use. There was no obvious defect or damage seen on the dialyzer. The patient¿s estimated blood loss (EBL) was approximately 250mL. The patient was restarted on a new machine and treatment completed successfully with new supplies. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50804935 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
A user facility¿s registered nurse (RN) reported that an external dialyzer blood leak occurred with one hour remaining in a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, did not alarm but was not expected to. A FME bloodline and dialyzer were in use. The leak originated from the arterial connection between the bloodline and dialyzer. It is unclear if the cause of the blood leak was a dialyzer or bloodline malfunction. The patient¿s estimated blood loss (EBL) was approximately 10mL. The patient did not continue treatment after the incident because they only had 45 minutes remaining. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation. Two photos have been provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50789220 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
A user facility¿s registered nurse (RN) reported that a visible external dialyzer blood leak occurred during a patient¿s hemodialysis (HD) treatment. The patient¿s estimated blood loss (EBL) is unknown. The complaint device is not available to be returned to the manufacturer for evaluation. Multiple attempts have been made to contact the customer to obtain additional information related to the reported event. At this time, no additional information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753638 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753549 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50714920 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50702522 ↗MalfunctionSep 4, 2026Fluid/Blood Leak
A user facility¿s registered nurse (RN) reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (HD) treatment. The leak was not visually observed. The machine, a FME 2008T machine, alarmed appropriately with a blood leak alarm. Blood leak test strips were used and tested positive for the presence of blood. A FME bloodline was in use. There was no obvious defect or damage seen on the dialyzer. The patient¿s estimated blood loss (EBL) was approximately 500mL. The patient was restarted on the same machine and treatment completed successfully with new supplies. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation. Three photos have been provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50614620 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50550918 ↗MalfunctionAug 31, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50532413 ↗MalfunctionAug 31, 2026Fluid/Blood Leak
A user facility¿s Clinic Manager (CM) reported that a visible internal dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (HD) treatment. The patient¿s estimated blood loss (EBL) is unknown. The complaint device is not available to be returned to the manufacturer for evaluation. Multiple attempts have been made to contact the customer to obtain additional information related to the reported event. At this time, no additional information has been provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50524790 ↗MalfunctionAug 28, 2026Fluid/Blood Leak
A user facility's dialysis manager reported that a 2008T Hemodialysis (HD) Machine had blood in it due to a dialyzer blood leak during a patient¿s hemodialysis (HD) treatment. A FME Field Service Technician (FST) was called onsite and bleached the machine and replaced the balance chamber assembly, flow pump head and various tubing. Machine functional tests were completed and passed onsite after repair. Upon follow up, the dialysis manager said that the dialyzer leak was a visible internal dialyzer blood leak that occurred thirty minutes after the initiation of the patient¿s hemodialysis (HD) treatment. The machine alarmed appropriately with a blood leak alarm. Blood leak test strips were used and tested positive for the presence of blood. A FME bloodline was in use. There was no obvious defect or damage seen on the dialyzer. The patient¿s estimated blood loss (EBL) was approximately 30mL. The patient was restarted on a new machine and treatment completed successfully with new supplies. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation. Multiple attempts have
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50501075 ↗MalfunctionAug 26, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50456966 ↗MalfunctionAug 26, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50453055 ↗MalfunctionJul 29, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50077606 ↗
Other Dialyzer, high permeability with or without sealed dialysate system devices
- 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
- PRISMAFLEX SET M100Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system2 recalls1 death150 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.