2008T BlueStar Hemodialysis MachineRecalls & reported problems across all models

We found 4 models of 2008T BlueStar Hemodialysis Machine by Fresenius Medical Care Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 767 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2018 and Sep 30, 2026 — classified as 22 deaths, 34 injuries, 711 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (337 reports).

11 FDA recall records name at least one of these models by its device identifier, 11 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

2008T BlueStar Hemodialysis Machine 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. Jun 30, 2026Open, Classified

   Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines.

   Z-3017-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. Aug 8, 2024Open, 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 4 of these models · Recall details · FDA record ↗

3. Apr 17, 2024Open, 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-1870-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Apr 17, 2024Open, 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-1869-2024 · Root cause: Device Design · Recall details · FDA record ↗

5. Apr 17, 2024Open, 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-1868-2024 · Root cause: Device Design · Recall details · FDA record ↗

6. Apr 17, 2024Open, 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-1867-2024 · Root cause: Device Design · Recall details · FDA record ↗

7. Sep 6, 2023Open, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0035-2024 · Root cause: Device Design · Recall details · FDA record ↗

8. Sep 6, 2023Open, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0034-2024 · Root cause: Device Design · Recall details · FDA record ↗

9. Sep 6, 2023Open, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0033-2024 · Root cause: Device Design · Recall details · FDA record ↗

10. Sep 6, 2023Open, Classified

    Potential PCBA leaching from tubing of hemodialysis machines.

    Z-0032-2024 · Root cause: Device Design · Recall details · FDA record ↗

11. Jul 27, 2022Open, 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 ↗

Most reported 2008T BlueStar Hemodialysis Machine problems

2008T BlueStar Hemodialysis Machine models

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

• 2008T BlueStar Hemodialysis Machine 191126

  Dialyzer, high permeability with or without sealed dialysate system
  5 recalls10 deaths441 reports
• 2008T BlueStar Hemodialysis Machine 191130

  Dialyzer, high permeability with or without sealed dialysate system
  4 recalls7 deaths272 reports
• 2008T BlueStar Hemodialysis Machine 191124

  Dialyzer, high permeability with or without sealed dialysate system
  4 recalls32 reports
• 2008T BlueStar Hemodialysis Machine 191128

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls5 deaths22 reports

Recent 2008T BlueStar Hemodialysis Machine adverse event reports

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

• MalfunctionSep 30, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine showed signs of burnt and charred wires. 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 50951832 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak; Device Damaged by Another Device

  A nurse reported that there was a blood leak during a hemodialysis (HD) treatment. The machine began alarming "air". Once inspected, it was noted that blood was leaking from the line on the blood pump area. After removal of combi set in blood pump, there was a puncture mark in the tubing allowing blood to leak and air to get into the section of the blood line that was in the blood pump. In a follow up, the nurse said the blood leak occurred approximately 2 hours 15 min after Hemodialysis (HD) treatment was started. There was and air detected alarm on the 2008T machine. An Optiflux dialyzer was being used.The leak was due to the combiset line being punctured or split. Obvious damage to the bloodline was noticed when the line was removed from the blood pump rotor.There were no loose connections noted. There was damage seen to the tubing. The rotor part number is F40014866. It was determined the blood pump rotor was faulty and it was replaced.It had not been replaced before. The rotor was an affected rotor. The patient¿s blood loss was approximately 100mL. There was no patient injury, intervention or adverse event. The patient completed treatment with new bloodlines and a different ma

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50935161 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Arrest

  MAUDE report 50918636 ↗
• MalfunctionSep 17, 2026No Audible Alarm; Alarm Not Visible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808535 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  On 31/Aug/2026, Fresenius Medical Care (FME) became aware this patient with renal failure (RF) on hemodialysis (HD) utilizing a 2008T Hemodialysis System for renal replacement therapy (RRT) expired while undergoing HD on (b)(6) 2026. Follow-up with the clinical charge nurse (CCN) revealed the 2008T Hemodialysis System evaluation took place on (b)(6) 2026 and it was returned to service on (b)(6) 2026 after disinfection. The CCN stated there were no adverse findings during the evaluation, nor did the 2008T Hemodialysis System require any repair, aside from calibrating the ultrafiltration (UF) pump. The patient was in critical condition and had already suffered several cardiac arrests (specifics not provided) prior to attempting ¿urgent start¿ HD. The CCN stated there was no concern a FME device(s) and/or product(s) caused or contributed to the patients cardiac arrest or death. The 2008T Hemodialysis System was sequestered following the serious adverse events. On 8/Sep/2026, an FME field service technician (FST) was dispatched to perform post-event functional compliance testing. The device passed all functional compliance testing (e.g., self-tests, conductivity, temperature, pH, simul

  Patient problems: Insufficient Information

  MAUDE report 50808534 ↗
• MalfunctionSep 16, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine¿s heparin pump was not working. During repair the BMT observed arcing and discoloration marks on the 8-pin component of the distribution board. The BMT reported that there was no melting, burning smell, smoke, spark, or flame observed. The machine has not had any past problems with failing the electrical leakage test and there was no damage observed to any other components. The machine has approximately 2,200 hours and is plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet. A FME Field Service Technician (FST) was called onsite and confirmed the arcing as well as discoloration on the heating block and signs that the wires had loosened causing a buildup of heat. The FST replaced the distribution board to resolve the issues. Machine functional tests were completed and passed onsite after repair. There was blood loss, patient serious injury or adverse events reported. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789341 ↗
• MalfunctionSep 4, 2026Thermal Decomposition of Device

  A Fresenius Field Service Technician (FST) was called on-site to service a 2008T hemodialysis (HD) machine that would not power up. The FST found a burnt spot on the motherboard, which caused chain reaction of multiple boards to be damaged. The FST replaced the Power control board, main power cable, motherboard, and UI board for power issue. The FST replaced the actuator board for new found issue, ACT Fail Error with troubleshooting power issue. The FST replaced the Sensor BD fo Cond Offset Reference Failure and would not let the FST calibrate the conductivity cells until the sensor board was replaced. The FST replaced the concentrate connector and threaded end because they were fused together. The FST also used a one-year PM kit to replace o-rings, circlip and spacer to complete concentrate connector. There was no patient involvement or patient injury noted. Additional information was requested but was not received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611914 ↗
• MalfunctionAug 25, 2026Thermal Decomposition of Device

  A Biomedical Technician (BMT) reported to Technical Support that a 2008T machine was powering down as soon as it goes into a mode. Technical Support had the BMT turn off the heater breaker. When going into rinse, the machine stayed on. Technical Support advised swapping the heater rod. Upon follow up, the BMT replaced the heater cord after it was found to be burnt out to resolve the issue. The machine is back in service. It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue. No pictures were provided. No part number or Lot number of the part was provided. No parts are available for return. Upon further follow up, the BMT reported that there was no observed burning smell, smoke, spark, flame, arcing. The machine powering down occurred during setup for treatment. The BMT was not at the machine and could not report the machine hours, software version, or e-codes. The cord was the original part on the machine. The machine has not had any past problems with failing electrical leakage tests. The machine is plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet. There was no damage to any other components r

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434656 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Fresenius technical support (TS) that a patient experienced hypernatremia during hemodialysis (HD) treatment on a Fresenius 2008T machine. In an email response from the user facility, it was documented that on (b)(6) 2026, the patient had a pre-dialysis treatment sitting blood pressure (BP) of 146/92 mmHg, pulse 81, respirations 18, temperature 97.5°F, and a weight of 69.0 kg. Additionally, it was noted that standard pre-treatment safety checks were completed which included HD machine self-tests, dialysate conductivity checks, and external Phoenix conductivity and pH verification. The Fresenius HD machine showed conductivity of 14.0 mS/cm with verified independent meter (Phoenix) conductivity of 14.0 mS/cm and pH 7.0 which were within facility parameters. There were no pre-treatment machine abnormalities or failed tests documented. It was documented that approximately 2.5 hours into the HD treatment the patient developed acute nausea, active vomiting, headache, and reported double vision, accompanied by marked hypertension and tachycardia. It was documented that the patient¿s blood pressure was 195/110 mmHg with persistent severe hypertension (range mid-160s to h

  Patient problems: Diplopia/Double Vision; Headache; High Blood Pressure/ Hypertension; Hypernatremia; Nausea; Tachycardia; Vomiting

  MAUDE report 50182372 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Fresenius technical support (TS) that a patient experienced hypernatremia during hemodialysis (HD) treatment on a Fresenius 2008T machine. In an email response from the user facility, it was documented that on (b)(6) 2026, the patient had a pre-dialysis treatment blood pressure (BP) of 146/78 mmHg with pulse of 75 bpm. Additionally, it was noted that standard pre-treatment safety checks were completed which included HD machine self-tests, dialysate conductivity checks, and external Phoenix conductivity and pH verification. There were no pre-treatment machine abnormalities or failed tests documented. It was documented that at the end of the HD treatment the patient developed severe hypertension with associated symptoms of nausea, headache, neck pain, and vomiting. The patient¿s BP averaged mid-160s/80s which then increased to 174/88 mmHg within the last hour of the HD treatment. The last documented BP was 188/98 mmHg with a pulse of 107 bpm at the end of the patient¿s HD treatment. As a result, the patient¿s HD treatment was discontinued and the patient was given clonidine 0.2 mg orally for hypertension. The treating nephrologist was notified of the event, and the

  Patient problems: Headache; High Blood Pressure/ Hypertension; Hypernatremia; Nausea; Neck Pain; Tachycardia; Vomiting

  MAUDE report 50182370 ↗
• MalfunctionJul 20, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine emitted a burning smell during cleaning mode. A Fresenius Field Service Technician (FST) was called onsite and ordered a UI/ MICS board for the customer. Upon follow up, the BMT said that the user interface (UI) board and its cable had a burning smell and the UI/ MICS board was burnt. 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 machine remains out of service as they are waiting for a part to arrive. 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 25876231 ↗
• MalfunctionJun 26, 2026Thermal Decomposition of Device

  A Biomedical Technician (BMT) reported to Technical Support that a 2008T machine experienced fails multiple self-tests including TMP high soft, act temp high, act temp low, temp high soft, and conductivity high. The BMT stated the temperature was 37.1°C and did not change during the self-test. Customer replaced the actuator-test board. Customer placed the device in self-test twice during the call. The BMT stated the device was now functioning normally and passes the self-test. Upon follow-up, the BMT stated that it was a short electrical issue with the bicarb pump. The BMT was not able to provide more information. No photos were available and no parts were returned for evaluation. The BMT confirmed there was no patient involvement, harm, or adverse events associated with the reported issue. The machine is back in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643990 ↗
• MalfunctionJun 22, 2026Thermal Decomposition of Device

  A user facility reported that the machine would not complete heat disinfection. The heater rod was replaced as the heater rod was discolored. Upon follow up, it was reported that there was thermal damage on the heater rod. The heater rod was replaced and the machine was able to go through heat disinfection. There was no patient involvement as the reported issue was noted during heat disinfection. The heater rod was discarded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579898 ↗
• MalfunctionJun 5, 2026Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A 2008T MACHINE WAS POWERING OFF WHEN ATTEMPTING TO PUT IT INTO A RINSE CYCLE OR DIALYSIS MODE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED REFERENCED THE TROUBLESHOOTING MANUAL AND IT ADVISED TO CHECK THE ACTUATOR BOARD. UPON INSPECTION OF THE BOARD, THE BIOMED NOTICED THERMAL DAMAGE (A BLACK SPOT). THE BIOMED REPLACED THE ACTUATOR BOARD WITH A SPARE AND THIS RESOLVED THE ISSUE. THERE WAS NO BURNING SMELL NOTED. THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THE BIOMED CONFIRMED THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND IT DID NOT HAVE A HISTORY OF FAILING THE ELECTRICAL LEAKAGE TEST. THE BIOMED STATED THE MACHINE HAS ABOUT 16,000 HOURS ON IT. NO PHOTOS OF THE DAMAGED BOARD WERE AVAILABLE. THE BOARD WAS NOT AVAILABLE TO BE SENT BACK FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. THE MACHINE WAS RETURNED TO SERVICE UPON COMPLETION OF THE REPAIR. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408891 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A HEMODIALYSIS (HD) PATIENT SUFFERED A CARDIAC ARREST WHILE UNDERGOING HD THERAPY ON A 2008T HD MACHINE. FOLLOW-UP WITH THE INPATIENT CHARGE NURSE (ICN) REVEALED THE PATIENT SUFFERED A CARDIAC ARREST WHILE UNDERGOING HD ON (B)(6) 2026. THE ICN REPORTED HD WAS IMMEDIATELY TERMINATED AND CARDIOPULMONARY RESUSCITATIVE (CPR) MEASURES WERE PERFORMED. THE PATIENT WAS SUCCESSFULLY REVIVED AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOLLOWING THE SERIOUS ADVERSE EVENTS. THE PATIENT REMAINED IN THE ICU AT THE TIME OF FOLLOW-UP AND WAS UNDERGOING HD WITHOUT ANY KNOWN ISSUES. PER THE ICN, THE HD MACHINE WAS PULLED FROM SERVICE DUE TO POLICY AND PROCEDURE FOLLOWING A CODE SITUATION, AND NOT BECAUSE A FRESENIUS DEVICE DEFICIENCY OR MALFUNCTION WAS SUSPECTED. THE HD MACHINE WAS FIRST EVALUATED BY THE BIOMED AND FUNCTIONED AS EXPECTED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING ON 8/MAY/2026. THE 2008T HD MACHINE PASSED ALL FUNCTIONAL COMPLIANCE CHECKS AND WAS RETURNED TO SERVICE THAT SAME DAY.

  Patient problems: Cardiac Arrest

  MAUDE report 25325598 ↗

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