FX CorAL 80 Dialyzer F00009217Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00840861102648), received between Sep 10, 2025 and Feb 9, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Obstruction of Flow

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS CORAL DIALYZER CAUSED FREQUENT ALARMS, CLOTTING AND BLOOD BACKING UP TO THE VENOUS TRANSDUCER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. SYSTEM CHANGES, CHANGING THE VENOUS TRANSDUCER AND OTHER TROUBLE SHOOTING DID NOT RESOLVE THE ISSUE. 500CC OF NORMAL SALINE WERE USED TO PRIME THE LINE AND THE DIALYZER WAS ALSO TAPPED DURING PRIMING. A FRESENIUS 2008T MACHINE AND A FRESENIUS BLOODLINE WERE ALSO IN USE. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24292415 ↗
• MalfunctionFeb 9, 2026Obstruction of Flow

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS CORAL DIALYZER CAUSED FREQUENT ALARMS, CLOTTING AND BLOOD BACKING UP TO THE VENOUS TRANSDUCER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. SYSTEM CHANGES, CHANGING THE VENOUS TRANSDUCER AND OTHER TROUBLE SHOOTING DID NOT RESOLVE THE ISSUE. 500CC OF NORMAL SALINE WERE USED TO PRIME THE LINE AND THE DIALYZER WAS ALSO TAPPED DURING PRIMING. A FRESENIUS 2008T MACHINE AND A FRESENIUS BLOODLINE WERE ALSO IN USE. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24292358 ↗
• MalfunctionFeb 9, 2026Obstruction of Flow

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS CORAL DIALYZER CAUSED A TRANS-MEMBRANE PRESSURE (TMP) ALARM, FLOODING OF THE VENOUS TRANSDUCER LINE, CLOTTING AND A FAILURE TO KEEP UP WITH THE BLOOD FLOW RATE DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A TMP ALARM. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24292225 ↗
• MalfunctionFeb 9, 2026Obstruction of Flow

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT FRESENIUS CORAL DIALYZER CAUSED TRANS-MEMBRANE PRESSURE (TMP) ALARMS, HIGH VENOUS PRESSURE AND CLOTTING 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24291896 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED THREE HOURS 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. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT DID NOT COMPLETE TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY ISSUES DUE TO NOT COMPLETING TREATMENT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24201740 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED FOUR HOURS AND FIFTEEN 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. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24178196 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  ON 16/JAN/2026, FRESENIUS RECEIVED A PRODUCT COMPLAINT FORM REGARDING THIS 40-YEAR-OLD FEMALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A FX CORAL FX80 HF DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED A PROBABLE DIALYZER REACTION DURING HD THERAPY ON (B)(6) 2026. THE PATIENT WAS REPORTEDLY TRIALING A NEW TYPE OF DIALYZER (FX CORAL FX80 HF DIALYZER), HOWEVER AFTER APPROXIMATELY 10 MINUTES INTO TREATMENT THE PATIENT COMPLAINED OF MILD GENERALIZED ITCHINESS (PRURITUS). THE TREATMENT WAS REPORTEDLY HALTED, AND A NEW EXTRACORPOREAL CIRCUIT WAS PRIMED UTILIZING A NIPRO CELLENTIA 17H DIALYZER. FOLLOW-UP WITH THE PATIENT¿S HD REGISTERED NURSE (HDRN) REVEALED IMMEDIATELY AFTER (INITIAL REPORT STATED 10 MINUTES) THE INITIATION OF TREATMENT, THE PATIENT REPORTED GENERALIZED PRURITUS. THE PATIENT¿S TREATMENT WAS DISCONTINUED WITHOUT RETURNING THE PATIENT¿S EXTRACORPOREAL BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250 ML, AND SHE WAS GIVEN BENADRYL 25MG (ROUTE NOT PROVIDED) FOR THE PRURITUS. THE PATIENT¿S TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME HD MACHINE, UTILIZING A NIPRO CELLENTIA 17H DIALYZER. PER THE HDR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24137030 ↗
• InjuryJan 21, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  ON 16/JAN/2026, FRESENIUS RECEIVED A PRODUCT COMPLAINT FORM REGARDING THIS 40-YEAR-OLD FEMALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) UTILIZING A FX CORAL FX80 HF DIALYZER FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY EXPERIENCED A PROBABLE DIALYZER REACTION DURING HD THERAPY ON (B)(6) 2026. THE PATIENT WAS REPORTEDLY TRIALING A NEW TYPE OF DIALYZER (FX CORAL FX80 HF DIALYZER), HOWEVER AFTER APPROXIMATELY 10 MINUTES INTO TREATMENT THE PATIENT COMPLAINED OF MILD GENERALIZED ITCHINESS (PRURITUS). THE TREATMENT WAS REPORTEDLY HALTED, AND A NEW EXTRACORPOREAL CIRCUIT WAS PRIMED UTILIZING A NIPRO CELLENTIA 17H DIALYZER. FOLLOW-UP WITH THE PATIENT¿S HD REGISTERED NURSE (HDRN) REVEALED IMMEDIATELY AFTER (INITIAL REPORT STATED 10 MINUTES) THE INITIATION OF TREATMENT, THE PATIENT REPORTED GENERALIZED PRURITUS. THE PATIENT¿S TREATMENT WAS DISCONTINUED WITHOUT RETURNING THE PATIENT¿S EXTRACORPOREAL BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250 ML, AND SHE WAS GIVEN BENADRYL 25MG (ROUTE NOT PROVIDED) FOR THE PRURITUS. THE PATIENT¿S TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME HD MACHINE, UTILIZING A NIPRO CELLENTIA 17H DIALYZER. PER THE HDR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction

  MAUDE report 24132670 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A VISIBLE INTERNAL DIALYZER BLOOD LEAK OCCURRED TWO MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. 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 250ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24131001 ↗
• MalfunctionDec 9, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A FRESENIUS CORAL FX80 DIALYZER HAD AIR IN IT CAUSING A BLOOD CLOT AND SUBSEQUENT BLOOD LOSS THIRTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO IN USE. THE ARTERIAL BLOOD WAS RETURNED; HOWEVER THE VENOUS WAS NOT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 150ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT¿S NEEDLE CLOTTED AS WELL. THEY RE-CANNULATED AND PULLED BACK CLOTS UPON ACCESSING SO THEY ENDED TREATMENT EARLY. THE PATIENT DID NOT HAVE ANY ISSUES AS A RESULT OF ENDING THE TREATMENT EARLY. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23759697 ↗
• MalfunctionDec 9, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A FRESENIUS CORAL FX80 DIALYZER HAD AIR IN IT CAUSING A BLOOD CLOT AND SUBSEQUENT BLOOD LOSS TWO HOURS AND THIRTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO IN USE. THE ARTERIAL BLOOD WAS RETURNED; HOWEVER THE VENOUS WAS NOT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 150ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23759328 ↗
• MalfunctionDec 9, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A FRESENIUS CORAL FX80 DIALYZER HAD AIR IN IT CAUSING A BLOOD CLOT AND SUBSEQUENT BLOOD LOSS THREE HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. 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. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23759318 ↗
• MalfunctionDec 9, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A FRESENIUS CORAL FX80 DIALYZER HAD AIR IN IT CAUSING A BLOOD CLOT AND SUBSEQUENT BLOOD LOSS OCCURRED TWO HOURS AND THIRTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. 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. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23759164 ↗
• MalfunctionDec 9, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A FRESENIUS CORAL FX80 DIALYZER HAD AIR IN IT CAUSING A BLOOD CLOT AND SUBSEQUENT BLOOD LOSS ONE HOUR AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO IN USE. THE ARTERIAL BLOOD WAS RETURNED; HOWEVER THE VENOUS WAS NOT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 150ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23759112 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED FORTY MINUTES AFTER THE INITIATION OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT WAS DID NOT RESTART TREATMENT. 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 23696807 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED TWO HOURS AND FIFTEEN MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THE PATIENT WAS RESTARTED WITH NEW SUPPLIES ON A NEW MACHINE. 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 23696749 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/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 23618268 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A 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 23594770 ↗
• MalfunctionSep 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS CORAL DIALYZER CLOTTED 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 23016592 ↗