FX CorAL 100 Dialyzer F00009218Recalls & reported problems
Fresenius Medical Care Holdings, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840861102655), received between Feb 17, 2026 and Mar 31, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
Patient problems
- Hemorrhage/Blood Loss/Bleeding5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Fluid/Blood Leak
A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS 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 24742597 ↗MalfunctionMar 31, 2026Fluid/Blood Leak
A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS 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 24742596 ↗MalfunctionMar 31, 2026Fluid/Blood Leak
A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS 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 24742594 ↗MalfunctionMar 16, 2026Fluid/Blood Leak
A USER FACILITY'S REGISTERED NURSE (RN) REPORTED THAT A VISIBLE INTERNAL DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS 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 24606175 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED THREE HOURS AND TWENTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THE PATIENT OPTED NOT TO COMPLETE TREATMENT FOLLOWING THE ISSUE. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24365503 ↗
Other Dialyzer, High Permeability With Or Without Sealed Dialysate System devices
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- 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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