Hemoflow™ 0520161ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840861100026), received between Mar 16, 2020 and Oct 15, 2025 — classified as 1 injury, 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A VISIBLE INTERNAL DIALYZER BLOOD LEAK OCCURRED TWO HOURS AND FIFTEEN MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM BECAUSE THE BLOOD HAD NOT YET REACHED THE BLOOD LEAK DETECTOR BEFORE THE LEAK WAS DISCOVERED. BLOOD LEAK TEST STRIPS WERE NOT USED. FRESENIUS BLOODLINES WERE NOT IN USE. 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 DID NOT RESTART TREATMENT. THE COMPLAINT SAMPLE IS NOT AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23301796 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) 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 NOT USED. FRESENIUS BLOODLINES WERE NOT IN USE. 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 DID NOT FINISH THE TREATMENT. THE COMPLAINT SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23300953 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S MEDICAL DOCTOR REPORTED THAT A VISIBLE EXTERNAL DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED WITH A ¿HIGH ARTERIAL PRESSURE¿ ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. FRESENIUS BLOODLINES WERE ALSO IN USE. THERE DIALYZER WAS NOTED TO BE LEAKING FORM THE HEADER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200ML. THERE WAS NO PATIENT 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 DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20745970 ↗
• MalfunctionFeb 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY 2 HOURS AND 50 MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE, A GAMBRO PHOENIX MACHINE (NOT A FRESENIUS PRODUCT), ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 82 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT ENDED TREATMENT EARLY AS ONLY 10 MINUTES OF TREATMENT REMAINED AT THE TIME OF THE EVENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480470 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A DIALYZER LEAKED IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE RN VISUALLY OBSERVED THAT THE DIALYZER LEAKED FROM TWO LOCATIONS. THE FIRST LEAK OCCURRED TWO INCHES BELOW THE HEADER CAP OF THE DIALYZER. THE SECOND LEAK OCCURRED WITHIN A FIBER. THE DIALYZER LEAKS WERE CONFIRMED TO BE INTERNAL. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED TO TEST FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543465 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BIOMED REPORTED THAT THE LEAK WAS COMING FROM THE BLUE HANSEN CONNECTOR. THE MACHINE BEING USED WAS REPORTED TO BE A GAMBRO PHOENIX. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE BIOMED. THE BIOMED STATED THAT THE LEAKING BEGAN DURING THE PRIMING STAGE. IT WAS CONFIRMED THAT THE LEAK WAS NOTED BY THE STAFF. HOWEVER, THE LEAK (REPORTED TO BE JUST ¿DROPS¿) WAS NOT SIGNIFICANT AND THERE WERE NO REPORTED MACHINE ALARMS. AS A RESULT, THE STAFF ELECTED TO PROCEED WITH THE TREATMENT. DURING THE TREATMENT, THE LEAKING CONTINUED. ALTHOUGH THE DIALYZER WAS LEAKING DURING TREATMENT, THE BIOMED STATED THERE WAS NO BLOOD LOSS. THE ONLY FLUID THAT LEAKED FROM THE DEVICE WAS DIALYSATE. THERE WERE NO RECORDED MACHINE ALARMS OR PRESSURE ISSUES. THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITH THE ORIGINAL DIALYSIS SET-UP. GAMBRO BLOODLINES WERE BEING UTILIZED DURING THE TREATMENT AND IT WAS CONFIRMED THAT THE MACHINE WAS A GAMBRO PHOENIX. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408368 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BIOMED REPORTED THAT THE LEAK WAS COMING FROM THE BLUE HANSEN CONNECTOR. THE MACHINE BEING USED WAS REPORTED TO BE A GAMBRO PHOENIX. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE BIOMED. THE BIOMED STATED THAT THE LEAKING BEGAN DURING THE PRIMING STAGE. IT WAS CONFIRMED THAT THE LEAK WAS NOTED BY THE STAFF. HOWEVER, THE LEAK (REPORTED TO BE JUST ¿DROPS¿) WAS NOT SIGNIFICANT AND THERE WERE NO REPORTED MACHINE ALARMS. AS A RESULT, THE STAFF ELECTED TO PROCEED WITH THE TREATMENT. DURING THE TREATMENT, THE LEAKING CONTINUED. ALTHOUGH THE DIALYZER WAS LEAKING DURING TREATMENT, THE BIOMED STATED THERE WAS NO BLOOD LOSS. THE ONLY FLUID THAT LEAKED FROM THE DEVICE WAS DIALYSATE. THERE WERE NO RECORDED MACHINE ALARMS OR PRESSURE ISSUES. THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITH THE ORIGINAL DIALYSIS SET-UP. GAMBRO BLOODLINES WERE BEING UTILIZED DURING THE TREATMENT AND IT WAS CONFIRMED THAT THE MACHINE WAS A GAMBRO PHOENIX. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408367 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BIOMED REPORTED THAT THE LEAK WAS COMING FROM THE BLUE HANSEN CONNECTOR. THE MACHINE BEING USED WAS REPORTED TO BE A GAMBRO PHOENIX. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE BIOMED. THE BIOMED STATED THAT THE LEAKING BEGAN DURING THE PRIMING STAGE. IT WAS CONFIRMED THAT THE LEAK WAS NOTED BY THE STAFF. HOWEVER, THE LEAK (REPORTED TO BE JUST ¿DROPS¿) WAS NOT SIGNIFICANT AND THERE WERE NO REPORTED MACHINE ALARMS. AS A RESULT, THE STAFF ELECTED TO PROCEED WITH THE TREATMENT. DURING THE TREATMENT, THE LEAKING CONTINUED. ALTHOUGH THE DIALYZER WAS LEAKING DURING TREATMENT, THE BIOMED STATED THERE WAS NO BLOOD LOSS. THE ONLY FLUID THAT LEAKED FROM THE DEVICE WAS DIALYSATE. THERE WERE NO RECORDED MACHINE ALARMS OR PRESSURE ISSUES. THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITH THE ORIGINAL DIALYSIS SET-UP. GAMBRO BLOODLINES WERE BEING UTILIZED DURING THE TREATMENT AND IT WAS CONFIRMED THAT THE MACHINE WAS A GAMBRO PHOENIX. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408365 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY NURSE MANAGER REPORTED THAT A HEMODIALYSIS (HD) PATIENT HAD A CHANGE IN THEIR HD PRESCRIPTION DUE TO A POSSIBLE DIALYZER REACTION. THE REACTION WAS MILD AND DID NOT REQUIRE MEDICAL INTERVENTION DURING THE TREATMENT. THE PATIENT REPORTED NOT FEELING WELL AT TREATMENT INITIATION. THEY WERE GIVEN GUM AND CANDY AS IT WAS SUSPECTED THE SALINE COULD BE CAUSING A BAD TASTE FOR THE PATIENT. THE PATIENT REPORTEDLY COMPLETED THEIR 2-HOUR SCHEDULED HD TREATMENT WITH NO FURTHER ISSUES. FOLLOWING THIS TREATMENT, THE PATIENT WAS SWITCHED TO THE FRESENIUS F40 HEMOFLOW DIALYZER FROM THE FRESENIUS F4 DIALYZER. THE F4 DIALYZER USED FOR THE TREATMENT WAS REPORTEDLY UNAVAILABLE TO BE RETURNED FOR A PHYSICAL EVALUATION. DIALYZER LOT INFORMATION AND ADDITIONAL PATIENT DETAILS WERE NOT PROVIDED. IT WAS LATER REPORTED THAT THE PATIENT WAS SWITCHED FROM THE FRESENIUS F4 DIALYZER TO THE FRESENIUS F40S STEAM STERILIZED DIALYZER, NOT TO THE F40 HEMOFLOW DIALYZER. THE LOT NUMBERS FOR BOTH DEVICES WERE PROVIDED.

  Patient problems: Malaise

  MAUDE report 10095025 ↗
• MalfunctionMar 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY PATIENT CARE MANAGER REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED FORTY-FIVE MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS REPORTED TO BE COMING FROM A CRACK THAT WAS IDENTIFIED IN THE HEADER OF THE DIALYZER. NOTHING UNUSUAL WAS NOTED DURING PRIMING OR SETUP. THE MACHINE, A GAMBRO PHOENIX, DID NOT ALARM. FRESENIUS BLOODLINES WERE NOT USED FOR THE TREATMENT; A GAMBRO CARTRIDGE BLOOD SET WAS IN USE AT THE TIME OF THE EVENT. BLOOD LEAK TEST STRIPS WERE USED, AND THEY TESTED NEGATIVE FOR BLOOD FROM THE DIALYZER PORTS. AFTER IDENTIFYING THE BLOOD LEAK, TREATMENT WAS PAUSED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 117 ML. THE PATIENT CARE MANAGER STATED THERE WAS NO HARM TO THE PATIENT DURING OR AFTER THE INCIDENT. IT WAS ALSO CONFIRMED THAT NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE DIALYZER WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836562 ↗