FX CorAL F00012970Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04039361259570), received between Feb 16, 2026 and Sep 24, 2026 — classified as 8 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  A nurse reported a dialyzer blood leak associated with a patient during hemodiafiltration (HDR) treatment. In a follow up, a nurse said the leak occurred about 1-2 minutes after the start of the hemodialysis (HD) treatment. The leak was seen internal within the system. Blood tests strips were used and tested positive for the presence of blood.The leak was an internal leak. The 2008T machine did alarm with a blood leak alarm. Fresenius bloodlines were being used.There was no damage noted on the dialyzer. There was patient blood loss of 150 to 200mL. There was no patient injury, adverse event or medical intervention reported. The patient did complete treatment on different machine and new supplies. The device is available to be returned to the manufacturer for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50883994 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Chills; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Nausea; Vomiting

  MAUDE report 50856857 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  On 10/Sep/2026, Post Market Surveillance at Fresenius Medical Care RTG, LLC was notified of a possible dialyzer reaction involving the Fresenius Coral FX HF80 Dialyzer. Additional information about the event was obtained through a follow-up call with the reporting RN. The hemodialysis RN indicated that this patient was admitted into the (b)(6)clinic on (b)(6)2026 and has been dialyzing with the Fresenius Coral FX HF80 dialyzer for end stage renal disease. Per the nurse, the patient also utilized this dialyzer for hemodialysis while overseas (additional information not provided). It was stated that this elderly patient (86 years old) has baseline nausea, vomiting and generalized malaise. Additional medical history provided included: Anemia in chronic kidney disease, Hypertension, Diabetes type 2, adult congenital heart disease (ACHD), Heart Failure with EF 60%, and Hyperlipidemia. On (b)(6)2026, this elderly female patient received her normally scheduled hemodialysis treatment for end stage renal disease via a Fresenius Coral FX HF80 dialyzer (LOT # not available). The patient¿s pre-treatment vital signs included blood pressure (BP) of 193/71, heart rate (HR) of 75, respiratory rate

  Patient problems: Chills; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Nausea; Vomiting

  MAUDE report 50856784 ↗
• MalfunctionAug 27, 2026Fluid/Blood Leak

  A nurse reported a dialyzer blood leak associated with hemodialysis (HD) treatment. There was a blood leaks on 2 separate dialysis machines on the same patient. Dialyzer was checked with a new set of blood leak test strips on the second machine after the first blood leak detected. In a follow up, the nurse said this happened about 80 to 90 minutes into the treatment, then switched to a second machine and it happened a second time. Both machines were tested with blood test strips from two different lots of strips. The leak definitely tested positive on strips and was not visibly seen. Blood leak was inside the dialyzer or machine as the machine alarmed. A 5008x machine with fresenius manufactured lines was used. No defect seen in the dialyzer, estimated blood loss was in 2 sets of lines as they were unable to rinse patient back. The patient was unable to complete treatment as they didn't want to be set up again, treatment was rescheduled. The patient had no coagulation issues noted. This patient had no injuries and no issues regarding the blood leak. Although patient had a history of cardiac issues there were no issues at all related to the treatment. According to the staff on the f

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50480032 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 50195016 ↗
• InjuryJul 7, 2026Fluid/Blood Leak

  A NURSE REPORTED A DIALYZER BLOOD LEAK DURING A HEMODIALYSIS (HD) TREATMENT. IN A FOLLOW UP, THE NURSE SAID THE LEAK OCCURRED AT THE END OF THE HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS DESCRIBED AS BEING AN INTERNAL LEAK AND WAS SEEN IN THE DIALYSATE CONNECTOR WASTE LINE WHERE FLUID WAS PINK. BLOOD TESTS STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE 5008X DIALYSIS MACHINE DID ALARM 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 WAS FINISHED WITH TREATMENT.THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25736499 ↗
• MalfunctionJun 17, 2026Fluid/Blood Leak

  A NURSE REPORTED THAT THERE WAS A DIALYZER BLOOD LEAK DURING A HEMODIALYSIS (HD) TREATMENT. IN A FOLLOW UP, THE NURSE REPORTED THAT THE BLOOD LEAK OCCURRED AT 3:19 MINUTES. THE NURSE EXPLAINED THAT THE LEAK WAS NOT SEEN VISUALLY. THE LEAK WAS AN INTERNAL LEAK. A BLOOD STRIP TEST WAS USED AND IT TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE 5008X MACHINE DID ALARM WITH A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 200ML. FRESENIUS BLOOD LINES WERE BEING USED.THERE WAS NO DAMAGE SEEN ON THE DIALYZER. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REPORTED.THERE WAS ONLY 18 MIN LEFT OF THE TREATMENT, SO THE PATIENT WAS NOT RESTARTED.THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25534662 ↗
• MalfunctionMay 28, 2026Fluid/Blood Leak

  A NURSE REPORTED A DIALYZER BLOOD LEAK ASSOCIATE WITH A HEMODIALYSIS (HD) TREATMENT. MACHINE ALARMED FOR BLOOD LEAK AND IT TESTED POSITIVE. ADDITIONAL INFORMATION WAS REQUESTED BUT NO DETAILS WERE PROVIDED. A SAMPLE DIALYZER WAS RETURNED FOR INVESTIGATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25324119 ↗
• MalfunctionMay 28, 2026Fluid/Blood Leak

  A NURSE REPORTED THAT DURING HEMODIALYSIS (HD) TREATMENT THERE WAS A DIALYZER BLOOD LEAK. THE MACHINE ALARMED FOR BLOOD LEAK AND EFFLUENT DRAINAGE TESTED POSITIVE FOR BLOOD. TREATMENT TERMINATED, BLOOD NOT RETURNED. MACHINE PULLED FROM FLOOR. SAMPLE HAS BEEN RETURNED. ADDITIONAL INFORMATION WAS REQUESTED BUT NO DETAILS HAVE BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25323626 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  A FACILITY ADMINISTRATOR REPORTED TO FRESENIUS MEDICAL CARE VIA EMAIL THAT AN FXCORAL FX80 HAD A CRACKED HEADER, CAUSING A COPIOUS LEAK OF SALINE AND DIALYSATE DURING PRIMING, WITH A VISIBLE CRACK ACROSS THE ENTIRE DEPTH OF THE HEADER. IN A FOLLOW UP, THE FACILITY ADMINISTRATOR CONFIRMED THE ISSUE WAS NOTED DURING PREPARATION. THEY STATED THE DIALYZER WAS CRACKED ON BOTH SIDES OF THE BLOOD PORT. THE DIALYZER WAS PULLED OFF TO THE SIDE AND REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WERE NO MACHINE ALARMS (NON EXPECTED). IT WAS CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE. THE BIOMED TECH (BMT) VERIFIED THAT THE DIALYZER WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223968 ↗
• MalfunctionMay 6, 2026Fluid/Blood Leak

  A NURSE REPORTED A DIALYZER BLOOD LEAK ASSOCIATED WITH HEMODIALYSIS (HD) TREATMENT. THE NURSE STATED THAT AN FX CORAL FX80 HF 24/CS 1.8SA STEAM WAS USED FOR TREATMENT AND A BLOOD LEAK OCCURRED. IN A FOLLOW UP, THE NURSE SAID THE BLOOD LEAK OCCURRED 2HOURS AND 24 MINUTES INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE NURSE CONFIRMED THAT 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. THE LEAK WAS VISUALLY OBSERVED IN THE EFFLUENT DIALYSATE. STATED THAT FRESENIUS BLOODLINES WERE USED FOR TREATMENT AND THAT THE LEAK WAS INTERNAL. STATED THAT THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. CONFIRMED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT¿S TREATMENT WAS CONSIDERED COMPLETED AND PATIENT WAS NOT RESTARTED. THE DIALYZER IS AVAILABLE TO RETURN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25095356 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IN A FOLLOW UP FOR A RECEIVED/USED DIALYZER, THE NURSE REPORTED THERE WAS A DIALYZER BLOOD LEAK DURING A HEMODIALYSIS (HD) TREATMENT. THE NURSE STATED THAT AN FX CORAL FX80 HF 24/CS 1.8SA STEAM WAS USED FOR TREATMENT AND A BLOOD LEAK OCCURRED. THE BLOOD LEAK OCCURRED 3HOURS INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE NURSE CONFIRMED THAT 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. THE LEAK WAS NOT VISUALLY OBSERVED. STATED THAT FRESENIUS BLOODLINES WERE USED FOR TREATMENT, HOWEVER, BLOODLINE INFORMATION WAS UNKNOWN. CONFIRMED THAT THE LEAK WAS INTERNAL. STATED THAT THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 275 ML. CONFIRMED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT¿S TREATMENT WAS CONSIDERED COMPLETED AND PATIENT WAS NOT RESTARTED.STATED THAT THE DIALYZER WAS AVAILABLE AND HAS ALREADY BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25050409 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  A TECHNICIAN REPORTED A DIALYZER BLOOD LEAK DURING AUTO-SUB PLUS TREATMENT HEMODIAFILTRATION (HDF). IN A FOLLOW UP,A NURSE SAID FX CORAL FX80 HF 24/CS 1.8SA STEAM WAS USED FOR TREATMENT AND A BLOOD LEAK OCCURRED. IT IS UNKNOWN HOW LONG INTO TREATMENT THE BLOOD LEAK OCCURRED DURING PATIENT¿S HEMODIALYSIS (HD) TREATMENT. CONFIRMED THAT 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. THE LEAK WAS VISUALLY OBSERVED AT THE ARTERIAL END OF THE DIALYZER. IT WAS CONFIRMED THAT THE LEAK WAS COMING FROM THE DIALYZER AND NOT THE BLOODLINES. STATED THAT FRESENIUS BLOODLINES WERE USED FOR TREATMENT, HOWEVER, BLOODLINE INFORMATION WAS UNKNOWN. CONFIRMED THAT THE LEAK WAS INTERNAL. STATED THAT THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300-400 ML. CONFIRMED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25038062 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINICAL MANAGER REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED TWO HOURS AND FORTY MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT IS UNKNOWN IF THE LEAK WAS VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A FRESENIUS BLOODLINE WAS ALSO 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 250ML. THE PATIENT DID NOT RESTART TREATMENT AND ENDED ONE HOUR AND FIVE MINUTES EARLY. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THREE PHOTOS HAVE BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24839693 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINICAL MANAGER REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED FIFTEEN MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. A FRESENIUS BLOODLINE WAS ALSO 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 A NEW 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 24674848 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED THREE HOURS AND FIVE 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. A FRESENIUS BLOODLINE WAS ALSO 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 250ML. THE PATIENT DID NOT CONTINUE TREATMENT AND ENDED TWENTY-FIVE MINUTES EARLY. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24669092 ↗
• InjuryMar 20, 2026Fluid/Blood Leak

  ON 11/MAR/2026, FRESENIUS RECEIVED A PRODUCT COMPLAINT FORM REGARDING THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A FX CORAL FX80 HF DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED TWO BLOOD LEAK EVENTS ON (B)(6) 2026. THE PRODUCT COMPLAINT FORM (COMPLETED BY THE CLINICAL MANAGER) REVEALED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY 1.5 HOURS INTO THE PATIENT¿S HD TREATMENT. THE PATIENT WAS DIALYZED ON A FRESENIUS 5008X HEMODIALYSIS SYSTEM, WHICH REPORTEDLY ALARMED APPROPRIATELY WHEN THE INITIAL BLOOD LEAK OCCURRED. THE PATIENT¿S BLOOD WAS NOT RETURNED, RESULTING IN AN ESTIMATED BLOOD LOSS (EBL) OF APPROXIMATELY 300 ML. THE PATIENT¿S TREATMENT WAS RESTARTED ON A SEPARATE FRESENIUS 5008X HEMODIALYSIS SYSTEM, UTILIZING NEW SUPPLIES. APPROXIMATELY 30 MINUTES AFTER THE INITIATION OF THE SECOND TREATMENT, ANOTHER INTERNAL DIALYZER BLOOD LEAK OCCURRED (SEPARATE LOT NUMBER). AGAIN, THE FRESENIUS 5008X HEMODIALYSIS SYSTEM ALARMED APPROPRIATELY, AND THE PATIENT HAD AN ADDITIONAL EBL OF APPROXIMATELY 300 ML (TOTAL EBL = 600 ML). THE PATIENT DID NOT COMPLETE TREATMENT ON (B)(6) 2026, MISSING A TOTAL OF 3.75 HOURS OF TREATMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24650558 ↗
• InjuryMar 20, 2026Fluid/Blood Leak

  ON 11/MAR/2026, FRESENIUS RECEIVED A PRODUCT COMPLAINT FORM REGARDING THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A FX CORAL FX80 HF DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED TWO BLOOD LEAK EVENTS ON 11/MAR/2026. THE PRODUCT COMPLAINT FORM (COMPLETED BY THE CLINICAL MANAGER) REVEALED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY 1.5 HOURS INTO THE PATIENT¿S HD TREATMENT. THE PATIENT WAS DIALYZED ON A FRESENIUS 5008X HEMODIALYSIS SYSTEM, WHICH REPORTEDLY ALARMED APPROPRIATELY WHEN THE INITIAL BLOOD LEAK OCCURRED. THE PATIENT¿S BLOOD WAS NOT RETURNED, RESULTING IN AN ESTIMATED BLOOD LOSS (EBL) OF APPROXIMATELY 300 ML. THE PATIENT¿S TREATMENT WAS RESTARTED ON A SEPARATE FRESENIUS 5008X HEMODIALYSIS SYSTEM, UTILIZING NEW SUPPLIES. APPROXIMATELY 30 MINUTES AFTER THE INITIATION OF THE SECOND TREATMENT, ANOTHER INTERNAL DIALYZER BLOOD LEAK OCCURRED (SEPARATE LOT NUMBER). AGAIN, THE FRESENIUS 5008X HEMODIALYSIS SYSTEM ALARMED APPROPRIATELY, AND THE PATIENT HAD AN ADDITIONAL EBL OF APPROXIMATELY 300 ML (TOTAL EBL = 600 ML). THE PATIENT DID NOT COMPLETE TREATMENT ON (B)(6) 2026, MISSING A TOTAL OF 3.75 HOURS OF TREATMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24650535 ↗
• InjuryMar 20, 2026Fluid/Blood Leak

  ON 11/MAR/2026, FRESENIUS RECEIVED A PRODUCT COMPLAINT FORM REGARDING THIS 52-YEAR-OLD MALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A FX CORAL FX80 HF DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) SINCE 2021, THAT REPORTEDLY EXPERIENCED TWO BLOOD LEAK EVENTS ON (B)(6) 2026. THE PRODUCT COMPLAINT FORM (COMPLETED BY THE CLINICAL MANAGER) REVEALED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY 1.5 HOURS INTO THE PATIENT¿S HD TREATMENT (9:00 AM). THE PATIENT WAS DIALYZED ON A FRESENIUS 5008X HEMODIALYSIS SYSTEM, WHICH REPORTEDLY ALARMED APPROPRIATELY WHEN THE INITIAL BLOOD LEAK OCCURRED (VERIFIED VIA BLOOD LEAK TEST STRIP). THE PATIENT¿S BLOOD WAS NOT RETURNED, RESULTING IN AN ESTIMATED BLOOD LOSS (EBL) OF APPROXIMATELY 300 ML. THE PATIENT¿S TREATMENT WAS RESTARTED ON A SEPARATE FRESENIUS 5008X HEMODIALYSIS SYSTEM, UTILIZING NEW SUPPLIES. APPROXIMATELY 30 MINUTES AFTER THE INITIATION OF THE SECOND TREATMENT, ANOTHER INTERNAL DIALYZER BLOOD LEAK OCCURRED (SEPARATE LOT NUMBER). AGAIN, THE FRESENIUS 5008X HEMODIALYSIS SYSTEM ALARMED APPROPRIATELY (VERIFIED VIA BLOOD LEAK TEST STRIP), AND THE PATIENT HAD AN ADDITIONAL EBL OF APPROXIMATELY 300 ML (T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24649917 ↗
• InjuryMar 20, 2026Fluid/Blood Leak

  ON 11/MAR/2026, FRESENIUS RECEIVED A PRODUCT COMPLAINT FORM REGARDING THIS 52-YEAR-OLD MALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A FX CORAL FX80 HF DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) SINCE 2021, THAT REPORTEDLY EXPERIENCED TWO BLOOD LEAK EVENTS ON (b)(6) 2026. THE PRODUCT COMPLAINT FORM (COMPLETED BY THE CLINICAL MANAGER) REVEALED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY 1.5 HOURS INTO THE PATIENT¿S HD TREATMENT (9:00 AM). THE PATIENT WAS DIALYZED ON A FRESENIUS 5008X HEMODIALYSIS SYSTEM, WHICH REPORTEDLY ALARMED APPROPRIATELY WHEN THE INITIAL BLOOD LEAK OCCURRED (VERIFIED VIA BLOOD LEAK TEST STRIP). THE PATIENT¿S BLOOD WAS NOT RETURNED, RESULTING IN AN ESTIMATED BLOOD LOSS (EBL) OF APPROXIMATELY 300 ML. THE PATIENT¿S TREATMENT WAS RESTARTED ON A SEPARATE FRESENIUS 5008X HEMODIALYSIS SYSTEM, UTILIZING NEW SUPPLIES. APPROXIMATELY 30 MINUTES AFTER THE INITIATION OF THE SECOND TREATMENT, ANOTHER INTERNAL DIALYZER BLOOD LEAK OCCURRED (SEPARATE LOT NUMBER). AGAIN, THE FRESENIUS 5008X HEMODIALYSIS SYSTEM ALARMED APPROPRIATELY (VERIFIED VIA BLOOD LEAK TEST STRIP), AND THE PATIENT HAD AN ADDITIONAL EBL OF APPROXIMATELY 300 ML (T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24649910 ↗
• MalfunctionMar 11, 2026Obstruction of Flow

  A USER FACILITY'S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS CORAL DIALYZER DID NOT CLEAR AIR DURING PRIMING RESULTING IN AN "AIR DETECTOR" ALARM ON THE MACHINE DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT AND SUBSEQUENT BLOOD LOSS. UPON FOLLOW UP, THE RN SAID THAT IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT A FRESENIUS 2008T MACHINE DISPLAYED AN AIR DETECTOR ALARM. IT WAS DETERMINED AT THAT TIME THAT THE DIALYZER HAD CLOTTED. A FRESENIUS BLOODLINE WAS IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. IT IS UNKNOWN HOW MANY UNITS OF HEPARIN WERE IN USE. IT IS UNKNOWN HOW MUCH PRIME SOLUTION WAS USED. THE DIALYZER WAS ROTATED AND TAPPED DURING PRIMING. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24575234 ↗
• MalfunctionMar 5, 2026Obstruction of Flow

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS CORAL DIALYZER CAUSED TRANS-MEMBRANE PRESSURE (TMP) AND AIR DETECTOR ALARMS, FLOODING OF THE VENOUS TRANSDUCER LINE AND CLOTTING DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH TMP AND AIR DETECTOR ALARMS. IT IS UNKNOWN IF THERE WAS ANY BLOOD LOSS, PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. IT IS UNKNOWN IF THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY.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 24520397 ↗
• MalfunctionMar 5, 2026Obstruction of Flow

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS CORAL DIALYZER CAUSED TRANS-MEMBRANE PRESSURE (TMP) AND AIR DETECTOR ALARMS, FLOODING OF THE VENOUS TRANSDUCER LINE AND CLOTTING DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH TMP AND AIR DETECTOR ALARMS. IT IS UNKNOWN IF THERE WAS ANY BLOOD LOSS, PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. IT IS UNKNOWN IF THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY. 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 24520354 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  A USER FACILITY¿S NURSE MANAGER (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED WITH TWENTY-FOUR MINUTES REMAINING OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE PATIENT CHOSE NOT TO RESUME TREATMENT. 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 24344477 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  A USER FACILITY¿S NURSE MANAGER (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED TWO HOURS REMAINING OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. 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 24344447 ↗