Optiflux® 0500316ERecalls & reported problems

Fresenius Medical Care Holdings, Inc. · F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL · Class 2

All models of Optiflux (9)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Fresenius Optiflux is a single-use dialyzer used in dialysis treatment. Most of its 2,281 reports describe blood leaking from the device, and mention bleeding, 61 injuries and 7 deaths. Two open recalls concern press-on caps that need to be pressed firmly to stay secure, and cracked material that could cause internal blood leaks. Reports fell from 316 in the prior 12 months to 127 in the latest 12 months.

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: 2,282
Deaths reported: 7
Injuries reported: 61
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 2,282 adverse event reports that list this exact device (DI 00840861100149), received between May 26, 2017 and Sep 30, 2026 — classified as 7 deaths, 61 injuries, 2,214 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2,165 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

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 · Recall details · FDA record ↗
Dec 5, 2024Open, Classified
Potential for internal blood leaks due to cracked polyurethane
Z-0801-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Fluid/Blood Leak2,165
Adverse Event Without Identified Device or Use Problem50
Labelling, Instructions for Use or Training Problem47
Obstruction of Flow25
Leak/Splash8
Occlusion Within Device3
No Flow2
Coagulation in Device or Device Ingredient1

Patient problems

Hemorrhage/Blood Loss/Bleeding1,054
No Clinical Signs, Symptoms or Conditions681
No Known Impact Or Consequence To Patient512
Blood Loss29
Hypersensitivity/Allergic reaction25
Dyspnea19
Itching Sensation16
Reaction13

Recent adverse event reports

The 25 most recent of 2,282 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 50951569 ↗
MalfunctionSep 29, 2026Fluid/Blood Leak
A nurse reported that during a hemodialysis (HD) treatment there was a dialyzer blood leak. In a follow up, the nurse said the leak occurred at the start of the hemodialysis (HD) treatment. The leak was seen as being external at Hansen hoses. Blood tests strips were not used.The leak was external. The B-Braun machine Braun bloodlines were being used.There was no damage noted on the dialyzer. There was patient blood loss of 250mL. There was no patient injury, adverse event or medical intervention reported. The patient went to emergency department for lab draws. The device is not available to be returned to the manufacturer for evaluation.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50936382 ↗
MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50933825 ↗
MalfunctionSep 29, 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 machine, a FME 2008T machine, alarmed appropriately. 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 200mL. 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. Three photos were provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50927064 ↗
MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50926292 ↗
MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50923327 ↗
MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50822778 ↗
MalfunctionSep 16, 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 machine, a FME 2008H machine, alarmed appropriately with a blood leak alarm. Blood leak test strips were not used because the leak was visible. 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 125mL. 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. One photo has been provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50787017 ↗
MalfunctionSep 11, 2026Fluid/Blood Leak
A user facility Inventory Manager reported a dialyzer blood leak incident. The estimated blood loss (EBL) volume was unknown. Additional information was requested but was not received to date.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50740240 ↗
MalfunctionSep 10, 2026Fluid/Blood Leak
A user facility¿s inventory manager reported that a 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: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50714947 ↗
MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50702241 ↗
MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50681277 ↗
MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50677041 ↗
MalfunctionAug 28, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50500939 ↗
MalfunctionAug 28, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50500062 ↗
MalfunctionAug 12, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50218056 ↗
MalfunctionJul 17, 2026Fluid/Blood Leak
A USER FACILITY PATIENT CARE TECHNICIAN (PCT) NOTED APPROXIMATELY 5-10 MINUTES INTO TREATMENT A WEIRD PATTERN ON DIALYZER FIBERS. UPON FOLLOW UP, THE CLINIC MANAGER REPORTED THAT THE WEIRD PATTERN APPEARED TO BE A BLOOD CLOT TRAVELING OUTSIDE OF THE FIBERS. THE CLINIC MANAGER STATED THAT THE MACHINE, A FRESENIUS 2008T MACHINE WITH SERIAL NUMBER (B)(6), DID NOT ALARM WITH A BLOOD LEAK ALARM AND WAS PULLED FROM SERVICE. THE MACHINE WAS FIXED AND RETURNED TO SERVICE BUT IT IS UNKNOWN IF THE BLOOD LEAK DETECTOR NEEDED TO BE CALIBRATED, CLEANED, OR REPLACED. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE. THE LEAK WAS NOT VISUALLY OBSERVED JUST THE WEIRD PATTERN ON THE DIALYZER FIBERS. FRESENIUS BLOODLINES WERE USED FOR TREATMENT. THE CLINIC MANAGER REPORTED THAT THE LEAK WAS INTERNAL. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON A DIFFERENT MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE CLINIC MANAGER STATED THAT THE DIALYZER IS AVAILABLE TO BE RETURNED TO THE MAN
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25860642 ↗
MalfunctionJul 10, 2026Fluid/Blood Leak
A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS OPTIFLUX DIALYZER LEAKED FROM THE HEADER DURING PRIMING. THE DIALYZER APPEARED TO BE MALFORMED WHERE THE LINES ATTACH TO THE HEADER. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS ISSUE. THE ACTUAL COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782476 ↗
MalfunctionJul 10, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25782124 ↗
MalfunctionJul 9, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25772718 ↗
MalfunctionJul 8, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25750090 ↗
MalfunctionJun 26, 2026Fluid/Blood Leak
A SUPPLIES MANAGER REPORTED A DIALYZER BLOOD LEAK DURING A HEMODIALYSIS TREATMENT. IN A FOLLOW UP, A NURSE SAID THE LEAK OCCURRED ONE MINUTE INTO THE HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS DESCRIBED AS BEING INTERNAL AND WAS SEEN ON THE ARTERIAL HEADER WHERE THE FIBER WAS SEPARATED. BLOOD TESTS STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE FRESNIUS 2008T DIALYSIS MACHINE WAS USED AND ALARMED WITH A BLOOD LEAK ALARM. FRESENIUS BLOODLINES WERE BEING USED.THERE WAS NO DAMAGE NOTED ON THE DIALYZER. THERE WAS PATIENT BLOOD LOSS OF 200ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REPORTED. THE PATIENT FINISHED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25640553 ↗
MalfunctionJun 22, 2026Fluid/Blood Leak
A USER FACILITY¿S INVENTORY MANAGER REPORTED THAT A VISIBLE INTERNAL DIALYZER BLOOD LEAK OCCURRED ONE MINUTE AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW UP, THE FACILITY MANAGER (FA) SAID THAT THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A FRESENIUS BLOODLINE WAS NOT IN USE. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25578608 ↗
MalfunctionJun 18, 2026Fluid/Blood Leak
A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION REQUESTED BUT TO DATE HAS NOT BEEN OBTAINED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25547218 ↗
MalfunctionJun 2, 2026Fluid/Blood Leak
A BIOMEDICAL TECHNICIAN (BMT) REPORTED AN ISSUE WHEREAS A DIALYZER HAD AN IMPROPERLY SEATED TOP. THIS WAS NOTICED WHEN SETTING THE MACHINE UP PRIOR TO A TREATMENT. SALINE WAS LEAKING FROM TOP AND THE TECH REPLACED WITH INTACT DIALYZER. NO PATIENTS WERE AFFECTED. IN A FOLLOW UP, THE BMT VERIFIED THAT IT WAS DURING SETUP/INITIAL STARTUP THEY NOTICED THE LEAK. THE DIALYZER IS AVAILABLE FOR RETURN AS A SAMPLE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368564 ↗

Device details

UDI-DI	`00840861100149`
Brand	Optiflux®
Model	0500316E
Company	Fresenius Medical Care Holdings, Inc.
Product code	FJI · DIALYZER, CAPILLARY, HOLLOW FIBER
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 13, 2023

Device type (GMDN): Hollow-fibre haemodialysis dialyser, single-use

A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.

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All DIALYZER, CAPILLARY, HOLLOW FIBER devices →

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 · each recall links to the FDA recall notice
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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