5008X 03-5300-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00840861102518), received between Sep 17, 2025 and Sep 29, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K243505); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Aug 10, 2026Open, Classified

   Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

   Z-3085-2026 · Root cause: Component change control · Recall details · FDA record ↗

2. May 11, 2026Open, Classified

   Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

   Z-2702-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50932050 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50915758 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  A user facility¿s clinic manager (CM) reported that a FME 5008X bloodline leaked from the alpha clip on the arterial line during a patient¿s hemodialysis (HD) treatment. The patient¿s estimated blood loss (EBL) is unknown. There was no patient serious injury or medical intervention reported. 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 50915630 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A user facility¿s licensed practical nurse (LPN) reported that a 5008X bloodline leaked thirty minutes after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a FME 5008X machine, did not alarm, but was not expected to. A FME dialyzer was in use. The leak originated from the bottom of the venous chamber. The patient¿s estimated blood loss (EBL) was approximately 200mL. The patient was restarted on a new machine and treatment completed successfully with new supplies. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50858355 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A user facility¿s licensed practical nurse (LPN) reported that a 5008X bloodline leaked fifteen minutes after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a FME 5008X machine, did not alarm, but was not expected to. A FME dialyzer was in use. The leak originated from the arterial disc. The patient¿s estimated blood loss (EBL) was approximately 150mL. The patient was restarted on a new machine and treatment completed successfully with new supplies. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50858257 ↗
• MalfunctionSep 16, 2026Fluid/Blood Leak

  A user facility¿s registered nurse (RN) reported that a 5008X bloodline had a pin hole in the arterial tubing causing air to enter the bloodline five minutes after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a 5008X HD machine, alarmed appropriately with a blood leak alarm. A FME dialyzer was in use. The defect was noted to be right above where the arterial clamp is when the lines are on the machine. There were no loose connections or issues noted during priming. There were no changes in pressure or blood flow rate during treatment. The patient¿s estimated blood loss (EBL) is 300mL. The patient was restarted on the same machine and treatment completed successfully with new supplies. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50788683 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  A user facility¿s registered nurse (RN) reported that a 5008X bloodline leaked during a patient¿s hemodialysis (HD) treatment. The leak originated from under the arterial pressure dome. The patient¿s estimated blood loss (EBL) is unknown. 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 50753718 ↗
• MalfunctionJun 24, 2026Fluid/Blood Leak

  A user facility¿s Biomedical Technician (BMT) reported that a Fresenius 5008X Bloodline leak during a patient¿s hemodialysis (HD) treatment. The machine, a Fresenius 5008X machine, alarmed appropriately with a ¿EMB tray leak sensor¿ alarm. A Fresenius dialyzer was also in use. There were no loose connections or issues during priming. There were no changes in pressure or blood flow rate (BFR) during treatment. There was no defect or damage noted on the bloodline. The patient¿s estimated blood loss (EBL) was approximately 100mL. The patient was restarted on the same 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 available to be returned to the manufacturer for evaluation. Two photos have been provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25608705 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  A USER FACILITY'S REGISTERED NURSE (RN) REPORTED THAT A 5008X BLOODLINE LEAKED FROM THE BLOOD PUMP TUBING SEGMENT FIVE MINUTES AFTER THE INITIATION OF A PATIENT'S HD TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY WITH A FLUID DETECTION ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WAS NO VISIBLE DAMAGE TO THE BLOODLINE. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THE PATIENT WAS RESTARTED ON THE SAME 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 WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25084616 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED THREE HOURS AND FIFTEEN MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THE LEAK ORIGINATED FROM THE RED ALPHA CLIP. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 30ML. THE PATIENT WAS NOT RESTARTED THEREFORE TREATMENT ENDED THIRTY 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24859809 ↗
• MalfunctionApr 11, 2026Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A 5008X BLOODLINE LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE NURSE. APPROXIMATELY THIRTY MINUTES INTO THE TREATMENT, THE STAFF OBSERVED BLOOD DRIPPING FROM THE RED ALPHA CLIP LINE OF THE BLOOD TUBING SET. THERE WERE NO VISIBLE DEFECTS NOTED AT THE LEAK LOCATION, AND THERE WERE NO LOOSE CONNECTIONS. THERE WERE NO ALARMS FROM THE MACHINE, A 5008X MACHINE. NO LEAK WAS NOTED DURING THE PRIME, AND THERE WAS NO CHANGE OR DISRUPTION IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE PATIENT WAS UTILIZING AN FX CORAL DIALYZER. THE STAFF WAS ABLE TO REINFUSE THE PATIENT¿S BLOOD. ESTIMATED BLOOD LOSS (EBL) FROM THE LEAK WAS 5-10 ML. THERE WAS NO PATIENT SERIOUS 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 THE SAME MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24849117 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS 5008X BLOODLINE HAD A HOLE IN THE ARTERIAL LINE RESULTING IN A BLOOD LEAK THIRTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WERE NO CHANGES IN BLOOD FLOW RATE DURING TREATMENT. THERE WAS HIGH VENOUS PRESSURE DURING TREATMENT. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT DID NOT LOSE ANY BLOOD DUE TO THIS ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 0ML. 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 WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24753912 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS COMING FROM THE BLOOD PUMP TUBING SEGMENT OF A 5008X BLOODLINE. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE FACILITY. THE BLOOD LEAK WAS NOT NOTICED UNTIL AFTER THE PATIENT'S TREATMENT WAS COMPLETED. A T THE END OF THE TREATMENT WHEN THE SUPPLIES WERE BEING TAKEN DOWN, DROPS OF BLOOD WERE IDENTIFIED ON THE BLOOD PUMP. THE RN SAID THERE WERE NO ALARMS FROM THE 5008X MACHINE DURING THE TREATMENT. THE RN SAID THERE WERE NO KNOWN ISSUES THROUGHOUT THE DURATION OF THE TREATMENT. THERE WERE NO LOOSE CONNECTIONS NOTED, AND NO LEAKS NOTICED DURING THE PRIME. NO VISIBLE DEFECTS WERE NOTICED ON THE BLOODLINES. THE RN SAID BLOOD LOSS WAS MINIMAL. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS ABOUT 2 ML. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. PATIENT DETAILS WERE UNABLE TO BE PROVIDED. THE BLOODLINES WERE SENT BACK FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24274290 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS 5008X BLOODLINE LEAKED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK ORIGINATED FROM THE ALPHA CLIP NEAR THE BLOOD PUMP. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 20ML. 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 24178159 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS 5008X BLOODLINE LEAKED THREE HOURS AND FORTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, DID NOT ALARM, BUT IS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THE LEAK ORIGINATED FROM A DISCONNECTION WHERE THE ALPHA CLIP MEETS THE BLOODLINE. NO ISSUES WERE NOTED DURING PRIMING. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS NOT RESTARTED BECAUSE THERE WAS ONLY FIFTEEN MINUTES LEFT IN THEIR SCHEDULED TREATMENT TIME. THE PATIENT DID NOT EXPERIENCE ANY ISSUES AS A RESULT OF ENDING TREATMENT EARLY. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24162442 ↗
• MalfunctionJan 19, 2026Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A 5008X STANDARD BLOOD TUBING SET BLOOD LEAK OCCURRED THREE AND A HALF HOURS INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS REPORTEDLY COMING FROM THE ALPHA CLIP ON THE TUBING SET. NONE OF THE CONNECTIONS APPEARED TO BE LOOSE LEADING UP TO THE EVENT. HOWEVER, THE TUBING COMPLETELY SEPARATED AT THE LEAK LOCATION. THERE WERE NO MACHINE ALARMS THAT OCCURRED. THE BLOODLINES WERE INSPECTED FOR DEFECTS PRIOR TO USE WITH NO ANOMALIES NOTED. THERE WAS A VISIBLE, UNSPECIFIED DEFECT NOTED AFTER THE LEAK OCCURRED. THERE WERE NO LEAKS DURING THE PRIMING/SETUP. ADDITIONALLY, THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE PATIENT¿S BLOOD WAS ABLE TO BE REINFUSED WITHOUT ISSUE. ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS APPROXIMATELY 30ML. THE CM CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT DID NOT COMPLETE THEIR FULL TREATMENT. TREATMENT WAS NOT RESTARTED BECAUSE THE DIALYSIS SESSION WAS ALMOST OVER. THE SAMPLE WAS SENT BACK FOR MANUFACTURER EVALUATION

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24111211 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS 5008X BLOODLINE LEAKED SUBSTITUTION FLUID TWO AND A HALF HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY. THERE WAS A DISCONNECTION AT THE START OF THE SUBSTITUTION FLUID PUMP SEGMENT NOTED ON THE BLOODLINE. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO CHANGES TO PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THERE WERE NO ISSUES DURING PRIMING. THE PATIENT¿S BLOOD WAS COMPLETELY RINSED BACK USING SALINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 0ML. 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; HOWEVER SHE DID NOT HAVE THE TRACKING NUMBER AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003952 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS 5008X BLOODLINE LEAKED ONE AND A HALF HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE BLOODLINE. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO CHANGES TO PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THERE WERE NO ISSUES DURING PRIMING. 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 REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003810 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A CLINICAL MANAGER (CM) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE REPORTED ISSUE WAS IDENTIFIED APPROXIMATELY 1.5 HOURS AFTER TREATMENT INITIATION. THE PATIENT CARE TECHNICIAN (PCT) VISUALLY OBSERVED BLOOD TRICKLING DOWN FROM THE RED ALPHA CLIP ON THE 5008X BLOODLINES. NO DEFECT OR DAMAGE WAS NOTED TO THE BLOODLINES. TREATMENT WAS STOPPED. THE PATIENT WAS REINFUSED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 5 ML. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. TREATMENT CONTINUED WITH NEW SUPPLIES AFTER THE PATIENT WAS TRANSFERRED TO A DIFFERENT MACHINE. THE SAMPLE WAS CONFIRMED TO HAVE BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23877937 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED APPROXIMATELY TWO HOURS INTO HEMODIALYSIS (HD) TREATMENT, A CLINICIAN NOTICED BLOOD LEAKING DOWN FROM THE ALPHA CLIP. UPON FURTHER INSPECTION, BLOOD WAS IN FACT LEAKING FROM CONNECTION AT THE CLIP. THE PATIENT WAS REINFUSED AS THERE WAS NO AIR IN THE LINES. WHEN LINES WERE REMOVED FROM MACHINE, THEY COMPLETELY DISCONNECTED AT THE ALPHA CLIP. LINES WERE SAVED AND SENT OUT FOR EVALUATION. UPON FOLLOW-UP, THE CM STATED A PATIENT WAS TWO HOURS INTO DIALYSIS TREATMENT ON A FRESENIUS 5008X MACHINE WHEN STAFF NOTICED BLOOD LEAKING DOWN FROM THE ALPHA CLIP. TREATMENT WAS IMMEDIATELY HALTED. A FRESENIUS FX CORAL 60 DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS SUCCESSFULLY REINFUSED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 30 CC. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND REMAINED IN SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT WAS RESTARTED ON A DIFFERENT MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COM

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23439615 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED A 5008X HEMODIALYSIS (HD) MACHINE PROMPTED WITH AIR DETECT NEAR ARTERIAL PORT ALARMS DURING TREATMENT. THE AIR IN BLOODLINES ALARM WAS RESOLVED PER POLICY; HOWEVER THE ALARM KEPT RETURNING. CLINICIANS TRIED TO REINFUSE PATIENT IN ORDER TO SET UP NEW BLOODLINES, AND COULD NOT SUCCESSFULLY DO SO. BLOODLINES WERE SENT BACK FOR EVALUATION. UPON FOLLOW-UP, THE CM STATED A PATIENT WAS ONE HOUR A THIRTY MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 5008X MACHINE WHEN THE MACHINE PROMPTED AN ALARM INDICATING AIR DETECTED NEAR THE ARTERIAL PORT ALARMS. TREATMENT WAS HALTED AND THE STAFF WAS UNABLE TO LOCATE A LEAK OR DAMAGE TO THE BLOOD TUBING SET. A FRESENIUS FX CORAL 80 DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS UNABLE TO BE REINFUSED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250 CC. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND HAS REMAINED IN SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT WAS RESTARTED ON A DIFFERENT MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WIT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23439296 ↗
• MalfunctionSep 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS 5008X BLOODLINE WAS MISSING THE BLUE CLAMP AND HAD AIR IN THE LINE DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A 5008X HEMODIALYSIS (HD) MACHINE ALARMED APPROPRIATELY WITH AN "AIR DETECTED BELOW VENOUS CHAMBER" ALARM. AIR WAS VISIBLE IN THE LINE BELOW THE VENOUS CHAMBER. THE PATIENT'S BLOOD WAS NOT RETURNED FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT WAS REPORTED AT INTAKE THAT 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.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 23156216 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS 5008X BLOODLINE HAD AIR IN THE LINES DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE AIR ORIGINATED FROM THE ARTERIAL PRESSURE DOME. THE MACHINE, A FRESENIUS 5008X MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. 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 IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23073641 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243505. One submission often covers many models, so check the product and lot details in each record.

• Z-3087-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
• Z-3084-2026 · Aug 10, 2026 · Open, Classified
  5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
• Z-3086-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
• Z-0936-2026 · Oct 25, 2025 · Open, Classified
  5008X CAREsystem +CLiC +CDX;