5008X 03-5300-3CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840861102532), received between Nov 11, 2025 and Sep 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 18, 2026.

Recalls naming this device

1. Aug 10, 2026Class IIOpen, 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-3086-2026 · Root cause: Component change control · Recall details · FDA record ↗

2. May 11, 2026Class IIOpen, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  A user facility¿s facility administrator (FA)) reported that a FME 5008X bloodline leaked two hours after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a 5008X HD machine, alarmed appropriately. Blood leak test strips were used and tested positive for the presence of blood. A FME Coral dialyzer was in use. The leak originated from the ¿T¿ connection of the arterial line and the heparin line. There were no issues during priming and no loose connections. There was no change in pressure or blood flow rate during treatment. The patient¿s estimated blood loss (EBL) is 50mL. The patient chose not to complete treatment following the issue. There was no patient injury or medical intervention required due to the reported event. The complaint device is available to be returned to the manufacturer for evaluation. Four photos were provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50927012 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  A user facility¿s clinic manager (CM) reported that a FME 5008X bloodline leaked twelve minutes after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a 5008X HD machine, alarmed appropriately with blood leak and air in line alarms. A FME dialyzer was in use. The leak originated from the bottom of the venous chamber however, there was no visible damage. 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) is 300mL. 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 available to be returned to the manufacturer for evaluation. One photo has been provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50882514 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED A CIRCUIT LEAK. THE MACHINE DID NOT ALARM. BLOOD DID NOT GET NOTICED UNTIL DOORS WERE OPENED DURING RINSE BACK. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24518544 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  A USER FACILITY RETURNED A 5008X BLOODLINE TO THE MANUFACTURING PLANT FOR EVALUATION. ON THE FORM PROVIDED WITH THE RETURNED SAMPLE, IT WAS REPORTED THAT THE ALPHA CLIP CAME OUT, AND BLOOD LEAKED ONTO THE FRONT OF THE MACHINE. IT WAS REPORTED THAT THIS HAPPENED DURING THE RINSE BACK PHASE OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE CLINICAL MANAGER (CM) FROM THE USER FACILITY. A COMPLETE SEPARATION DID NOT OCCUR ON THE BLOODLINES. IT WAS UNKNOWN IF ANY MACHINE ALARMS OCCURRED. THE LINES WERE NOTED TO BE FREE OF DEFECTS PRIOR TO USE. THERE WAS A VISIBLE DEFECT NOTED AFTER THE LEAK. PER STAFF, THERE APPEARED TO BE A SMALL SPLIT IN THE LINE. THERE WAS NO LEAK NOTED DURING PRIME OR SETUP, AND THERE WAS NO CHANGE OR DISRUPTION IN PRESSURE. THE BLOOD LEAK RESULTED IN APPROXIMATELY 3-5 ML OF BLOOD LOSS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS/EVENTS OR REQUIRE MEDICAL INTERVENTION. NO FURTHER TREATMENT WAS NEEDED. A PHOTO WAS PROVIDED BY THE CM DEPICTING WHERE THE BLOOD WAS DRIPPING FROM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24370099 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT BLOOD DRIPPED OUT OF THE ALFA CLIP OF THE BLOOD PUMP OF THE 5008X BLOODLINES DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE FA STATED THAT ONLY A DROP OF BLOOD WAS NOTED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. THE PATIENT WAS REINFUSED AND TRANSFERRED TO A DIFFERENT MACHINE WHERE TREATMENT WAS COMPLETED WITH NEW SUPPLIES. THE FA DID NOT INSPECT THE BLOODLINES NOR WAS IT REPORTED TO THEM THAT ANY DEFECT OR DAMAGE WAS NOTED TO THE PRODUCT. THE SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23524570 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT BLOOD DRIPPED OUT OF THE ALFA CLIP OF THE BLOOD PUMP OF THE 5008X BLOODLINES DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE FA STATED THAT ONLY A DROP OF BLOOD WAS NOTED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. THE PATIENT WAS REINFUSED AND TRANSFERRED TO A DIFFERENT MACHINE WHERE TREATMENT WAS COMPLETED WITH NEW SUPPLIES. THE FA DID NOT INSPECT THE BLOODLINES NOR WAS IT REPORTED TO THEM THAT ANY DEFECT OR DAMAGE WAS NOTED TO THE PRODUCT. THE SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23524559 ↗

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-3084-2026 · Aug 10, 2026 · Open, Classified
  5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
• Z-3087-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
• Z-3085-2026 · Aug 10, 2026 · Open, Classified
  5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
• Z-0936-2026 · Oct 25, 2025 · Open, Classified
  5008X CAREsystem +CLiC +CDX;