2008 Series Hemodialysis MachinesRecalls & reported problems across all models

We found 10 models of 2008 Series Hemodialysis Machines by Fresenius Usa, Inc. in the FDA's device registry (GUDID). Together they are named in 1,768 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2015 and Sep 23, 2026 — classified as 76 deaths, 133 injuries, 1,559 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (801 reports).

15 FDA recall records name at least one of these models by its device identifier, 13 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

2008 Series Hemodialysis Machines 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. Aug 8, 2024Class IIOpen, Classified

   Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

   Z-3124-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

2. Jun 3, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-2347-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

3. Jun 3, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-2346-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

4. Jun 3, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-2345-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

5. Jun 3, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-2344-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

6. Jun 3, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-2343-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

7. Jun 3, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-2341-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

8. Jun 3, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-2340-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

9. Sep 6, 2023Class IOpen, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0031-2024 · Root cause: Device Design · Recall details · FDA record ↗

10. Sep 6, 2023Class IOpen, Classified

    Potential PCBA leaching from tubing of hemodialysis machines.

    Z-0030-2024 · Root cause: Device Design · Recall details · FDA record ↗

11. Sep 6, 2023Class IOpen, Classified

    Potential PCBA leaching from tubing of hemodialysis machines.

    Z-0029-2024 · Root cause: Device Design · Recall details · FDA record ↗

12. Sep 6, 2023Class IOpen, Classified

    Potential PCBA leaching from tubing of hemodialysis machines.

    Z-0028-2024 · Root cause: Device Design · Recall details · FDA record ↗

13. Jul 27, 2022Class IIOpen, Classified

    (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".

    Z-0734-2023 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

14. Dec 14, 2017Class IITerminated

    When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

    Z-1278-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

15. Oct 5, 2017Class IITerminated

    While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.

    Z-0829-2018 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗

Most reported 2008 Series Hemodialysis Machines problems

2008 Series Hemodialysis Machines models

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

• 2008® Series Hemodialysis Machines 190713

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls37 deaths893 reports
• 2008® Series Hemodialysis Machines 190766

  Dialyzer, high permeability with or without sealed dialysate system
  4 recalls15 deaths370 reports
• 2008® Series Hemodialysis Machines 190610

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall15 deaths335 reports
• 2008® Series Hemodialysis Machines 190895

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls2 deaths60 reports
• 2008® Series Hemodialysis Machines 190858

  Dialyzer, high permeability with or without sealed dialysate system
  2 recalls5 deaths81 reports
• 2008® Series Hemodialysis Machines 190395

  Hemodialysis system for home use
  3 recalls7 reports
• 2008® Series Hemodialysis Machines 190828

  Hemodialysis system for home use
  2 recalls8 reports
• 2008® Series Hemodialysis Machines 190904

  Hemodialysis system for home use
  2 recalls2 deaths8 reports
• 2008® Series Hemodialysis Machines 190630

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall6 reports
• 2008® Series Hemodialysis Machines 190908

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall0 reports

Recent 2008 Series Hemodialysis Machines adverse event reports

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

• MalfunctionSep 23, 2026Fluid/Blood Leak

  A user facility¿s registered nurse (RN) reported that a FME 2008T hemodialysis (HD) machine leaked from the blood pump segment two hours and fifty minutes after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, alarmed appropriately with an air detector alarm. A FME dialyzer was in use. The blood pump segment of the bloodline had a slit in it. The patient¿s estimated blood loss (EBL) was approximately 5mL. The patient was not restarted because they only had ten minutes left in their treatment. The machine was removed from service following the incident. The biomedical technician (BMT) was not able to find any issues with the blood pump; however, he did replace the blood pump and clip as a precaution because this is the second incident of this nature on this machine. 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 50868087 ↗
• MalfunctionSep 4, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine "burnt out" the heating rod. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. 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 50614080 ↗
• DeathAug 26, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026 a biomedical technician requested onsite service for machine verification following a hemodialysis (HD) patient incident on the 2008T Hemodialysis machine. The patient coded and passed away on the machine. Attempts to obtain additional information were unsuccessful. The Fresenius Medical Care field service technician (FST) evaluated the machine. The FST performed the Ultrafiltration (UF) problem identification checklist according to P/N 507162 Rev. G, performed UF pump calibration, verified 1.0CC/ML, functional checks were performed, and the machine was heat disinfected. The machine passed all functional testing. No further information was provided.

  Patient problems: Cardiac Arrest

  MAUDE report 50451622 ↗
• DeathAug 21, 2026Adverse Event Without Identified Device or Use Problem

  Fresenius Medical Care was made aware of a hemodialysis (HD) patient who expired after being transported from the HD clinic to the hospital after experiencing cardiac arrest on (b)(6) 2026. This patient arrived for a regularly scheduled 4-hour HD treatment utilizing the 2008T machine on (b)(6) 2026. At 0551 the patient¿s pre-treatment vitals were recorded as follows: sitting blood pressure (BP) 165/80, standing BP 157/73, pule 67, respirations 19, temperature 96.2. The patient was found to be 95.5kg, a gain of 3.0kg. The treatment records also documented use of Oxygen via nasal cannula at 2L/min. The patient was administered a heparin loading dose of 5,000 units at 0553 at which time hemoglobin labs were drawn. At 0555 the patient lines were connected to the patient. At 0557 the patient grabbed his chest and stated he did not feel well. The patient turned blue, 911 was called, and chest compressions were started. At 0603 emergency medical services (EMS) arrived in the parking lot and at 0605 EMS took over care of the patient. The patient arrived at the hospital after 7-8 minutes of chest compressions prior to arrival and had achieved return of spontaneous circulation (ROSC). The pa

  Patient problems: Cardiac Arrest

  MAUDE report 50376512 ↗
• MalfunctionAug 17, 2026Thermal Decomposition of Device; Melted

  A user facility biomedical technician (biomed) contacted Fresenius Medical Care (FME) technical support (TS) to report that a 2008K2 Hemodialysis machine would not power on. The biomed stated the machine stops during power-up (at 15% of initialization) and just audibly alarms. It does not continue powering up. During troubleshooting the biomed noticed a defective wire (scorched) on the power switch in the power supply. They replaced the power supply assembly with another module (unknown to be good or not). The biomed also replaced the motherboard. The biomed unplugged the actuator/sensor cables from the distribution board and the problem continues to occur. TS recommended the biomed replace the functional board or power logic board. The biomed was also advised to swap the power supply with a known good module. Upon follow-up with the biomed, it was reported that the power issue was resolved by replacing the functional board. The biomed said the replacement functional board was ordered through a third-party vendor, and the defective functional board was sent back to the vendor as part of an exchange. The biomed confirmed thermal damage was found during troubleshooting. One of the po

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287017 ↗
• MalfunctionAug 14, 2026Thermal Decomposition of Device

  A user facility¿s' biomedical technician (BMT) reported to FME Technical Support a 2008T machine experienced a ¿Conductivity Confirmation Cell Calibration Error¿ Message. Upon follow up, the BMT said that during repair it was discovered that the power cord was burned and blackened. The BMT reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed. The BMT reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components. The machine has approximately 39,000 hours and is plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet. The machine was returned to service after they replaced the power cord. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256403 ↗
• MalfunctionAug 11, 2026Thermal Decomposition of Device

  A user facility Biomedical Technician (BMT) reported to Technical Support a 2008T machine powers down on its own randomly. There was no patient involvement. The BMT swapped the power switch, keypad assembly and the power logic board. The BMT was advised to swap the power supply (to isolate), possible power control board issue, functional board, check the motherboard for any issues, check all cables for problems. Upon follow-up, the BMT stated they were still troubleshooting the reported issue, and the machine was still out of service. The BMT mentioned that the power switch was burned, so it was replaced. It was confirmed there was no patient involvement, harm, or adverse events associated with the reported issue. Additional information was requested but was not received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203347 ↗
• MalfunctionAug 11, 2026Thermal Decomposition of Device

  A user facility biomedical technician (biomed) reported to Fresenius technical support (TS) that a 2008T Hemodialysis machine was experiencing an issue with its display screen. The biomed stated the screen was black. The biomed said they had already replaced the UI mics board, the UI to function board ribbon cable, and the screen. TS advised the biomed to check the motherboard and all wired connections and connectors. Additional details were provided during follow-up with the biomed. Upon further investigation, the biomed identified thermal damage on the connector of the ground wire that goes from the power module to the main distribution board. The biomed replaced the whole power module (which included a new ground wire and connector), and this resolved the reported screen issue. No other components were found to be damaged. The distribution board did not have to be replaced. The biomed did not have any photos of the charred wire/connector. There was no burning smell noted, and there were no signs of any smoke, sparks, or flames. The biomed said the machine had 43,487 operating hours on it at the time of the event. The machine did not have any past problems failing the electrical

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202782 ↗
• MalfunctionAug 10, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine displayed a flow error in standby mode. A Fresenius Field Service Technician (FST) was called onsite and found multiple valves were corroded and the valve connections were melted. The FST replaced the balancing chamber assembly to resolve the issues. Machine functional tests were completed and passed onsite after repair. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. 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 50195897 ↗
• MalfunctionJul 20, 2026Thermal Decomposition of Device

  A user facility reported to Fresenius that a 2008T Hemodialysis (HD) machine was giving a conductivity low alarm. A field service technician (FST) was dispatched to the facility to evaluate the machine. The 2008T machine was out of service when the FST arrived onsite. The FST ran the machine in rinse and encountered a flow inlet error and check acid pump alarm. They noticed that the diasafe filter required replacement as it was thirty days past due. The FST indicated that this was possibly causing the flow inlet error. The diasafe filter was replaced. The FST noticed a burning smell, and thermal decomposition was identified once the distribution box was opened. The FST stated the distribution box 2 board and cable were burnt due to leaked concentrate. Photos were provided for review. The FST stated valve 105 looked rusted, and the acid port pressure transducer had signs of thermal decomposition - both parts are components of the distribution board assembly. The FST replaced the distribution board assembly and cable. The machine was still giving a flow inlet error after these parts were replaced. The biomed then replaced the actuator board and the bibag interface board and the alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882185 ↗
• MalfunctionJul 17, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25860716 ↗
• MalfunctionJul 16, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD A MELTED FLOAT SWITCH ON THE HYDROCHAMBER. THEY BMT HAD RECENTLY REPLACED THE HYDROCHAMBER AND WHEN THE DEVICE WAS POWERED ON, WATER WAS SPRAYING FROM THE VENT TUBE. THE BMT REMOVED THE FLOAT SWITCH AND FOUND IT WAS MELTED PREVENTING THE FLOAT FROM MOVING FREELY. UPON FOLLOW UP, THE BMT SAID THAT THE ISSUE WAS NOTICED DURING MACHINE REPAIR. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE HYDROCAHMBER WAS BRAND NEW AND THIS AS AN OUT-OF-BOX FAILURE. THE BMT REPORTED THAT THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 34,000 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE HYDROCAHMBER, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE HYDROCAHMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25840598 ↗
• MalfunctionJul 10, 2026Thermal Decomposition of Device

  A Fresenius Field Service Technician (FST) was called onsite to repair a 2008T hemodialysis (HD) machine with a burning smell. The cause was fluid dripped into the card cage and damage the bridge rectifier, causing the power supply to burn the wire and bridge rectifier. After replacing with the new power supply the HD machine power on and off without any issues. The HD machine completed repair as of 06/26/26. After replacing with the new power supply the HD machine was placed into dialysis treatment functional check/ test which passes 6x and completed repair with a vinegar/ heat as of 06/26/2026. There was no patient involvement or injury noted at intake. Additional information was requested but was not received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25780476 ↗
• MalfunctionJun 29, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED AN ¿E.08 +24V IS OUTSIDE ALLOWABLE RANGE¿ ERROR MESSAGE DURING RINSE MODE. UPON FOLLOW UP, THE BMT SAID THAT THEY REPLACED THE LP955 BOARD, BUT THAT DID NOT RESOLVE THE ISSUE. THEY THEN FOUND A BURNT, BROWN WIRE ON THE BRIDGE RECTIFIER CONNECTION ON THE POWER SUPPLY. THE BMT SAID THAT THE POWER SUPPLY WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED TO ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 30,000 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE POWER SUPPLY, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE POWER SUPPLY IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652964 ↗
• MalfunctionJun 22, 2026Fluid/Blood Leak

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THE VENOUS CHAMBER KEPT FILLING WITH BLOOD DURING DIALYSIS TREATMENT (TX) MODE. THERE WERE NO ADVERSE REACTIONS WITH THE PATIENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE DEVICE SINCE THE NURSE KEPT REPLACING THE EXTERNAL TRANSDUCER ON THE VENOUS PORT. THE BMT SWAPPED THE LEVEL DETECTOR MODULE AND THE PROBLEM DID NOT RESOLVE. TECHNICAL SUPPORT ADVISED THE BMT TO RE-CALIBRATE VENOUS/DIALYSATE PRESSURES AND CHECK THE TUBING CONNECTION AT THE LEVEL DETECTOR PRESSURE PORT TO VERIFY THE TUBING IS CORRECTLY INSTALLED. NEXT, THE BMT WAS ADVISED TO SWAP THE SENSOR, FUNCTIONAL OR MOTHERBOARDS TO RESOLVE THE ISSUE. UPON FOLLOW UP, THE BMT STATED THAT THE MOTHER BOARD WAS REPLACED TO RESOLVE THE ISSUE AND THE MACHINE HAS BEEN RETURNED TO SERVICE. THERE WERE NO INJURIES, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED TO THE PATIENT OR USER. THE BMT COULD NOT CONFIRM IF THE MOTHER BOARD WAS AVAILABLE TO BE RETURNED FOR ANALYSIS. UPON FURTHER FOLLOW UP, THE TECHNICIAN REPORTED THAT 30 MINUTES INTO TREATMENT THE TRANSDUCER WAS GETTING SOAKED WITH BLOOD RESULTING IN AN UNKNOWN AMOUNT OF BLOOD LOSS ON 6/1/2026. NO BLOOD WAS RETURNED TO THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25587530 ↗

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