Hemoflow™ 0520165ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840861100019), received between May 14, 2021 and Jul 10, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25784713 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S NURSE MANAGER REPORTED THAT A FRESENIUS DIALYZER LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT BECAUSE THE PROVIDED DIALYZER BLOOD PORT CAPS DID NOT FIT PROPERLY ON THE DIALYSATE PORTS. UPON FOLLOW UP, IT WAS DISCOVERED THAT THE BLOOD PORT CAPS THEY WERE USING WERE NOT MADE TO FIT ON THE DIALYSATE PORTS. WHEN THEY TESTED THE DIALYZER DURING TREATMENT, THE DIALYZER LEAK ABOUT 20ML OF DIALYSATE. THERE WAS NO PATIENT INVOLVEMENT, SERIOUS INJURY, OR ADVERSE EVENT REPORTED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23427087 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A VISIBLE INTERNAL DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER THE INITIATION OF THE 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. FRESENIUS BLOODLINES WERE ALSO IN USE. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 90ML. THERE WAS NO PATIENT 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 21112638 ↗
• MalfunctionJun 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE MACHINE WOULD NOT RESTART. A MANUAL RE-TRANSFUSION WAS PERFORMED. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17172937 ↗
• MalfunctionApr 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A DIALYZER BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. BLOOD WAS VISUALLY OBSERVED ON THE FLOOR (AT 16:25) BETWEEN THE GAMBRO PHOENIX (NON-FRESENIUS) MACHINE AND THE CHAIR. THE CLINICAL TEAM OBSERVED A LEAK COMING FROM THE VENOUS SIDE OF THE F3 DIALYZER. A CRACK WAS IDENTIFIED ON THE HEAD OF THE DIALYZER. TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD COULD NOT BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) COULD NOT BE DETERMINED BY THE CLINICAL TEAM. THE PATIENT DID NOT COMPLETE TREATMENT ON THE DAY OF THE EVENT. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT AS A RISK OF CONTAMINATION WAS PERCEIVED WITH THE EXTERNAL DIALYZER LEAK. THE PATIENT¿S HEMOGLOBIN & HEMATOCRIT (H&H) WERE TAKEN AND THE PATIENT¿S VITALS WERE FOUND TO BE STABLE. THE PATIENT RETURNED TO THE CLINIC THREE DAYS LATER ON (B)(6) 2023 FOR A FOLLOW-UP VISIT. THE PATIENT'S H&H WAS TAKEN AGAIN AND IT WAS DETERMINED THAT A TRANSFUSION WAS NOT REQUIRED. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777940 ↗
• MalfunctionDec 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT AN EXTERNAL BLOOD LEAK OCCURRED TWO HOURS INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS INITIALLY REPORTED THAT ¿A CRACK¿ WAS FOUND ON THE CLIC BLOOD CHAMBER. UPON FOLLOW-UP, IT WAS REPORTED THAT A COUPLE OF BLOOD DROPLETS WERE IDENTIFIED ON THE HD MACHINE WHICH WERE TRACED TO AN EXTERNAL LEAK FROM THE DIALYZER END CONNECTION OF THE CLIC BLOOD CHAMBER. AN EXTERNAL BLOOD LEAK WAS ALLEGED. REPORTEDLY, THE PATIENT¿S BLOOD HAD SEALED ITSELF OFF AT THE SITE OF THE LEAK. AS A RESULT, THE TREATMENT WAS CONTINUED AND COMPLETED WITH THE SAME SUPPLIES AND ON THE SAME MACHINE. DESPITE THE INITIAL ALLEGATION OF PHYSICAL DAMAGE, FOLLOW-UP CONFIRMED THAT NO CRACKS WERE VISUALLY IDENTIFIED ON THE CLIC BLOOD CHAMBER. THERE WERE NO MACHINE ALARMS ASSOCIATED WITH THE REPORTED FAILURE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 5 ML. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EFFECTS OR REQUIRED MEDICAL INTERVENTION. AS A PROPHYLACTIC MEASURE, THE PATIENT WAS ADMINISTERED AN ANTIBIOTIC INFUSION X1 (FURTHER DETAILS ON THIS WERE NOT PROVIDED). THE DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION. HOWEVER, A PHOTO OF THE DEVICE CONNECTED TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913704 ↗
• MalfunctionNov 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY PATIENT CARE MANAGER (PCM) REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AT THE START OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS REPORTED TO BE VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT OF THE DEVICE. A BLOOD LEAK TEST STRIP WAS USED AND TESTED POSITIVE. IT WAS CONFIRMED THAT THE MACHINE, A BAXTER PHOENIX, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALERT. NO VISIBLE DAMAGE WAS IDENTIFIED ON THE DIALYZER. THE PATIENT WAS DIALYZING WITH NEONATAL BLOODLINES (MANUFACTURER NOT SPECIFIED). AFTER THE MACHINE ALARMED, THE TREATMENT WAS HALTED. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS REPORTEDLY 64 ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE DIALYZER WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801231 ↗
• InjuryAug 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS UNDERGOING HD THERAPY WHEN A BLOOD LEAK OCCURRED. TWO HOURS AND FORTY-FIVE MINUTES INTO THE PATIENT'S TREATMENT, THE REGISTERED NURSE (RN) NOTICED BLOOD LEAKING FROM THE TOP OF THE HEMOFLOW F3 DIALYZER (WHERE THE CRIT-LINE DEVICE CONNECTS TO THE DIALYZER). THE ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20 ML. THE PATIENT¿S HD TREATMENT WAS STOPPED, AND THE RN ATTEMPTED TO RETURN THE PATIENT¿S BLOOD. WHILE RETURNING THE BLOOD, THE PATIENT¿S CENTRAL VENOUS CATHETER LINE CLOTTED (TREATED WITH CATHFLO, GOOD EFFECT), AND APPROXIMATELY 64 ML OF BLOOD COULD NOT BE RETURNED (APPROXIMATE TOTAL EBL = 84 ML). A COMPLETE BLOOD COUNT (CBC) WAS OBTAINED, WHICH REVEALED THE PATIENT¿S HEMOGLOBIN WAS 7.1 GM/DL AND HEMATOCRIT WAS 19.9%. THE DIALYZER WAS REPORTEDLY SEQUESTERED AND STORED FOR EVALUATION/TESTING. AS A RESULT OF THE LEAK, THE NEPHROLOGIST ORDERED ONE UNIT OF PEDIATRIC PACKED RED BLOOD CELLS (150 ML) TO BE ADMINISTERED AT THE NEPHROLOGY CLINIC ON 15/JUN/2021. THE PATIENT WAS TRANSFUSED WITHOUT ISSUE, AND REPEAT LABS SHOWED THE PATIENT¿S HEMOGLOBIN

  Patient problems: Anemia

  MAUDE report 12270698 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT A PATIENT DEVELOPED FEVER (UNKNOWN READING), AGITATION, LOW BLOOD PRESSURE (READING NOT AVAILABLE) AND TACHYCARDIA (RESULT NOT AVAILABLE) DURING RINSEBACK OF A HEMODIALYSIS (HD) TREATMENT. THE PATIENT RECEIVED DIALYSIS WITH A F3 DIALYZER. THE PATIENT WAS PREMEDICATED WITH ALBUMIN FLUSH OF THE DIALYZER AND IV METHYLPREDNISOLONE 10 MG IV. THE PATIENT WAS TREATED WITH SALINE ADMINISTRATION AND ANOTHER DOSE OF IV METHYLPREDNISOLONE. THE PATIENT ALSO RECEIVED PROPHYLACTIC ANTIBIOTIC (UNKNOWN MEDICATION). HOWEVER, THE DOCTOR SAID BLOOD CULTURES WHICH WERE OBTAINED, THE SAME DAY SHOWED THE PATIENT DID NOT HAVE AN INFECTION. SUBSEQUENTLY, THE PATIENT CONTINUED DIALYSIS WITH F3 DIALYZERS FROM DIFFERENT LOT (UNAVAILABLE) (DOCTOR SAID NO OTHER DIALYZER SMALL ENOUGH FOR PT. NEEDS) AND THE PATIENT WAS PREMEDICATED ½ HOUR BEFORE TREATMENT WITH KETOROLAC (DOSE UNKNOWN) IV, 20 MG METHYLPREDNISOLONE IV (INCREASE IN DOSE) AND ALBUMIN FLUSH OF THE DIALYZER AND THE PATIENT DID NOT HAVE ANY FURTHER REACTIONS. THE DOCTOR CONFIRMED THIS PATIENT SINCE RECEIVED A KIDNEY TRANSPLANT AND IS NO LONGER ON DIALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 11848096 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A CLINICAL MANAGER THAT THIS PATIENT ON HEMODIALYSIS (HD) EXPERIENCED ALLERGIC REACTIONS (DESPITE BEING PRE-MEDICATED) WHILE UTILIZING FRESENIUS HEMOFLOW F3 DIALYZERS AND THE BAXTER PHOENIX DIALYSIS MACHINE. THE CLINIC MANAGER HAD LIMITED CLINICAL INFORMATION TO PROVIDE ABOUT THE PATIENT¿S ALLERGIC REACTIONS. ADDITIONAL DETAILS ABOUT THE EVENTS WERE OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S DOCTOR WHO CONFIRMED THAT THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF AGITATION AND FEVER. IT WAS REPORTED THE PATIENT¿S SYMPTOMS DEVELOPED AT THE END OF THE HD TREATMENT AFTER UTILIZING THE FRESENIUS F3 HEMOFLOW DIALYZER. THE PATIENT ¿S DOCTOR STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL (THE SAME DAY). THE DOCTOR CONFIRMED THE PATIENT DID NOT HAVE AN INFECTION AND STATED THE PATIENT RECEIVED PROPHYLACTIC TREATMENT WITH AN UNKNOWN ANTIBIOTIC. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHIN 24 HOURS. NO FURTHER INFORMATION ABOUT THIS EVENT WAS PROVIDED. THE CLINICAL MANAGER WHO REPORTED THE ACTUAL HEMOFLOW F3 DIALYZERS USED DURING THE EVENT HAVE BEEN DISCARDED. HOWEVER, IT WAS STATED COMPANION SAMPLES OF THE HEMOFLOW F3 DIALYZER ARE AVAILABLE FOR RETURN TO THE MA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever; Hypersensitivity/Allergic reaction

  MAUDE report 11847878 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A CLINICAL MANAGER THAT THIS PEDIATRIC PATIENT ON HEMODIALYSIS (HD) EXPERIENCED ALLERGIC REACTIONS (CHARACTERIZED BY FUSSINESS AND ANGIOEDEMA) WHILE UTILIZING A FRESENIUS HEMOFLOW F3 DIALYZER AND THE BAXTER PHOENIX DIALYSIS MACHINE. THE CLINICAL MANAGER REPORTED THE PATIENT WAS PREMEDICATED IN ATTEMPT TO RESOLVE THE REACTIONS WHICH HAD LIMITED SUCCESS. THE PATIENT'S PHYSICIAN PROVIDED ADDITIONAL INFORMATION DURING FOLLOW-UP. THE PATIENT EXPERIENCED A DIALYZER REACTION WHILE RECEIVING DIALYSIS TREATMENT IN AN OUTPATIENT PEDIATRIC HD UNIT. IT WAS REPORTED THE PATIENT PRESENTED WITH SYMPTOMS OF AGITATION AND ANGIOEDEMA CHARACTERIZED WITH SWELLING/REDNESS OF THE EYES AND FACE APPROXIMATELY 30 MINUTES INTO TREATMENT. THE DOCTOR STATED THE PATIENT¿S BLOOD PRESSURE (B/P) WAS STABLE (MEASUREMENT UNKNOWN). AS A RESULT, THE PATIENT¿S HD TREATMENT WAS TERMINATED AND THE PATIENT WAS TREATED WITH NORMAL SALINE (150 ML), BENADRYL (10MG) AND SOLUMEDROL (10MG) INTRAVENOUSLY (IV). THE DOCTOR STATED THE PATIENT WAS SUBSEQUENTLY REINITIATED ON THE DIALYSIS TREATMENT WITH THE SAME DIALYZER. THE PATIENT REPORTEDLY TOLERATED THE REMAINDER OF THE DIALYSIS TREATMENT WITHOUT ANY FURTHER

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 11825620 ↗