CombiSetRecalls & reported problems across all models

We found 10 models of CombiSet by Fresenius Medical Care Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 819 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2015 and Sep 24, 2026 — classified as 11 deaths, 30 injuries, 778 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (749 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CombiSet recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 29, 2026Open, Classified

   Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

   Z-3225-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported CombiSet problems

CombiSet models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CombiSet 03-2722-9

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  8 deaths311 reports
• CombiSet 03-2522-1

  Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
  1 recall214 reports
• CombiSet 03-2622-3

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  1 death194 reports
• CombiSet 03-2742-9

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  2 deaths85 reports
• CombiSet 03-2692-6

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  5 reports
• CombiSet 03-2621-5

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  4 reports
• CombiSet 03-2962-3

  Hemodialysis system for home use
  3 reports
• CombiSet 03-2630-6

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  1 report
• CombiSet 03-2696-7

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  1 report
• CombiSet 03-2922-7

  SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  1 report

Recent CombiSet adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50889728 ↗
• MalfunctionSep 23, 2026Incomplete or Inadequate Connection

  A user facility¿s registered nurse (RN) reported that a FME Combiset bloodline experienced transducer issues from the venous line during a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, alarmed appropriately with trans-membrane pressure (TMP and venous pressure alarms. There were no loose connections or issues noted during priming. There were no changes in pressure or blood flow rate (BFR) during treatment. The patient completed treatment on the same machine after they replaced the transducer protector. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870270 ↗
• MalfunctionSep 23, 2026Incomplete or Inadequate Connection

  A user facility¿s registered nurse (RN) reported that a FME Combiset bloodline experienced transducer issues from the venous line during a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, alarmed appropriately with trans-membrane pressure (TMP and venous pressure alarms. There were no loose connections or issues noted during priming. There were no changes in pressure or blood flow rate (BFR) during treatment. The patient completed treatment on the same machine after they replaced the transducer protector. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870268 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  A user facility Registered Nurse (RN) reported a blood leak from the venous line. Upon follow-up, the RN stated a blood leak occurred from a small hole on the venous line tubing thirty minutes after initiation of hemodialysis (HD) treatment. The machine, a 2008T, did not alarm as the blood leak was visually detected and treatment was immediately halted. A Fresenius FX CorAL 60 dialyzer was being used during the incident. Blood test strips were not required or used. The patient's blood was not returned and the estimated blood loss (EBL) was 300 mL. The RN confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event. Following the event, the patient was re-setup with new supplies on a different machine and completed treatment without further issue. The Combi Set was discarded and was no longer available to be returned for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50768019 ↗
• MalfunctionAug 5, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143611 ↗
• MalfunctionAug 4, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136109 ↗
• MalfunctionJul 6, 2026Fluid/Blood Leak; Incomplete or Inadequate Connection

  A USER FACILITY FACILITY ADMINISTRATOR REPORTED THEY HAD BEEN NOTICING THAT THE BLOODLINES HAD SMALLER TRANSDUCERS AND WERE THINKING ARE THE REASON THEY HAVE BEEN CLOTTING A LOT OF MACHINES VENOUS CHAMBERS. THERE WAS NO REPORTED BLOOD LOSS NOTED AT INTAKE. THE SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718990 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717781 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717780 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717778 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717653 ↗
• MalfunctionJun 26, 2026Incomplete or Inadequate Connection

  A FACILITY ADMINISTRATOR REPORTED A TRANSDUCER WAS PULLING AIR INTO THE SYSTEM.THE TRANSDUCER POPPED OFF WHILE STARTING PATIENT. IN A FOLLOW UP, THE REPORTER SAID TREATMENT WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO BLOOD LOSS FOR THE PATIENT. THE BLOOD PUMP WAS STOPPED AND NEW TRANSDUCER WAS ADDED TO THE LINES. THERE IS NO SAMPLE/COMPANION AVAILABLE TO SEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640983 ↗
• MalfunctionJun 22, 2026Incomplete or Inadequate Connection

  A CHARGE NURSE REPORTED THAT TRANSDUCERS INCLUDED WITH THE COMBISET ARE INTERFERING WITH TREATMENTS. THERE ARE REOCCURRING TRANSMEMBRANE PRESSURE (TMP) ALARMS AND INCREASED PRESSURES IN VENOUS CHAMBER MAKING BLOOD BACKFLOW INTO LINES. 9 TIMES OUT OF 10, TRANSDUCERS WITH THE COMBISET ARE CHANGE OUT WITH THE SPARE TRANSDUCER SUPPLIES. THE NEW STYLE CAP ON THE END OF HEPARIN LINES DOES NOT THREAD AND SECURE EFFICIENTLY. WHEN PRESSURES BUILD UP, THE CAP HAS BLOOD OFF THE END, POTENTIALLY HAVING BLOOD LOSS. THE COMBISET FROM ABOUT A YEAR AGO WAS PROBABLY THE MOST EFFICIENT PRODUCT. UPON FOLLOW UP, THE NURSE REPORTED THAT THE 2008T WITH BIBAG MACHINES PRODUCE TMP ALARMS RIGHT BEFORE THE INCREASED PRESSURE IN THE VENOUS CHAMBER CAUSES BLOOD BACKFLOWS THROUGH THE LINES AND INTO THE SALINE. APPROXIMATELY 10-100ML OF BLOOD ENTERED THE SALINE AND THE BLOOD WAS NOT RETURNED. THE NURSE VERIFIED THAT THERE WERE NO EXTERNAL LEAKS. THE NURSE STATED THE FACILITY RECEIVES BOTH OLD AND NEW TYPES OF TRANSDUCERS BUT ONLY NOTICED ISSUES WITH THE REPORTED LOT NUMBER 26BR01045 SINCE 5/25/2026. THE NURSE STATED THAT THE NEW TRANSDUCER CAPS FOR THE HEPARIN LINE DON'T TIGHTEN ENOUGH AND FEEL LIKE THERE'S STR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25585440 ↗
• MalfunctionJun 22, 2026Incomplete or Inadequate Connection

  A HEMODIALYSIS (HD) PATIENT WAS CONNECTED TO A NEW MACHINE WITH NEW SUPPLIES. THE NURSE EXAMINED THE LINES WITH THE TRANSDUCER ON THE NEW 03-2522-1 COMBISET BLOODLINE, AND EVERYTHING APPEARED TO BE TIGHT. THEY BEGAN TO PRIME THE LINES, AND THE NURSE IMMEDIATELY SAW THE SALINE WENT INTO THE TRANSDUCERS. THE LINES WERE CHANGED AGAIN, AND THEY CHANGED THE TRANSDUCERS TO THE LARGER ONES, NOT THE ONES THAT COME ON THE 03-2522-1 COMBISET BLOODLINE. THERE WAS NO ISSUE WITH THE PRIMING OF THE LINES. THE PATIENT PROCEEDED TO UNDERGO TREATMENT AND COMPLETED THE FULL TREATMENT WITHOUT ANY FURTHER ISSUES. THE NURSE STATED THAT WHEN EXAMINING THE LINES, THE AIR WAS IN THE HEAD OF THE DIALYZER. THERE WAS NOTHING IN THE LINE FROM THE PATIENT TO THE MACHINE. THE AIR WAS FROM THE TRANSDUCER TO THE DIALYZER ONLY. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT. THERE IS NO SAMPLE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579719 ↗
• InjuryJun 22, 2026Incomplete or Inadequate Connection

  A NURSE REPORTED THAT DURING A HEMODIALYSIS (HD) TREATMENT A PATIENT DEVELOPED CHEST PAIN DURING TREATMENT DUE TO AIR IN THE LINE. 911 WAS CALLED DUE TO AIR IN THE LINES AND THE VENOUS CHAMBER CLOTTING WHICH RESULTED IN NOT BEING ABLE TO RETURN BLOOD TO THE PATIENT. THE PATIENT DEVELOPED SIGNS AND SYMPTOMS OF AIR EMBOLISM. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CLINICAL NURSE. THIS PATIENT WAS A FEW MINUTES INTO THE HEMODIALYSIS (HD) TREATMENT ON (B)(6) 2026 UTILIZING THE 03-2522-1 COMBISET BLOODLINE WHEN THE AIR DETECTORS ALARMED. THE PATIENT THEN TOLD THE PCT THAT THE PATIENT WAS NOT FEELING WELL. THE PCT TRIED TO RETURN THE PATIENT¿S BLOOD, BUT THE CHAMBER HAD ALREADY CLOTTED ON ONE SIDE. APPROXIMATELY 150ML OF BLOOD COULD NOT BE RETURNED. THE PATIENT THEN WENT UNCONSCIOUS. THE PATIENT HAD NO BLOOD PRESSURE (BP) READING AT THIS TIME. 911 WAS CALLED. THE CLINICAL NURSE CAME TO THE FLOOR. IT WAS THEN THAT SHE NOTED THE LINES AND CHAMBER WERE CLOTTED. AT THE SAME TIME, THE PATIENT WAS PLACED INTO TRENDELENBURG POSITION ON HIS LEFT SIDE FOR SUSPICION OF AIR EMBOLISM. THE NURSE STARTED A NEW INTRAVENOUS (IV) LINE TO ADMINISTER SALINE. 600ML OF NORMAL SALINE (N

  Patient problems: Chest Pain; Hemorrhage/Blood Loss/Bleeding; Loss of consciousness; Malaise

  MAUDE report 25579689 ↗

Other Fresenius Medical Care Holdings, Inc. products

• Liberty5 models · 11,598 reports · 1 recall
• Optiflux9 models · 5,700 reports · 3 recalls
• 2008T BlueStar Hemodialysis Machine4 models · 767 reports · 11 recalls
• stay.safe8 models · 187 reports · 6 recalls
• NaturaLyte2 models · 25 reports · 1 recall
• Bibag2 models · 0 reports · 1 recall
• Crit-Line2 models · 30 reports
• Hemoflow4 models · 29 reports