OptifluxRecalls & reported problems across all models

We found 9 models of Optiflux by Fresenius Medical Care Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 5,700 adverse event reports in the FDA's MAUDE database, received between Dec 30, 2015 and Sep 30, 2026 — classified as 17 deaths, 266 injuries, 5,417 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5,279 reports).

3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Optiflux recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 4 of these models · Recall details · FDA record ↗

2. Dec 5, 2024Open, Classified

   Potential for internal blood leaks due to cracked polyurethane

   Z-0801-2025 · Root cause: Process control · Recall details · FDA record ↗

3. May 4, 2022Terminated

   Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

   Z-1303-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Optiflux problems

Optiflux models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Optiflux® 0500318E

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall6 deaths2,849 reports
• Optiflux® 0500316E

  DIALYZER, CAPILLARY, HOLLOW FIBER
  2 recalls7 deaths2,282 reports
• Optiflux® 0500320E

  Dialyzer, high permeability with or without sealed dialysate system
  2 recalls242 reports
• Optiflux® 0500325E

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall1 death198 reports
• Optiflux® 0500318N

  Dialyzer, high permeability with or without sealed dialysate system
  2 deaths55 reports
• Optiflux® 0500308E

  Dialyzer, high permeability with or without sealed dialysate system
  28 reports
• Optiflux® 0500320N

  Dialyzer, high permeability with or without sealed dialysate system
  24 reports
• Optiflux® 0500306E

  Dialyzer, high permeability with or without sealed dialysate system
  13 reports
• Optiflux® 0500316N

  Dialyzer, high permeability with or without sealed dialysate system
  1 death9 reports

Recent Optiflux adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50951708 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50951569 ↗
• 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

  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 50934857 ↗
• 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 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 ↗

Other Fresenius Medical Care Holdings, Inc. products

• Liberty5 models · 11,598 reports · 1 recall
• 2008T BlueStar Hemodialysis Machine4 models · 767 reports · 11 recalls
• CombiSet10 models · 819 reports · 1 recall
• stay.safe8 models · 187 reports · 6 recalls
• NaturaLyte2 models · 25 reports · 1 recall
• Bibag2 models · 0 reports · 1 recall
• Crit-Line2 models · 30 reports
• Hemoflow4 models · 29 reports