Tablo(R) Hemodialysis System PN-0006000Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00850001011204), received between Aug 11, 2023 and Sep 23, 2026 — classified as 8 deaths, 24 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (11 reports).

4 FDA recall records name this device's identifier, 4 still open.

1 other recall cover devices cleared under the same FDA submission (K200741, K211370, K223248, K233335); 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 1, 2024Class IIOpen, Classified

   Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.

   Z-0019-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Mar 6, 2024Class IOpen, Classified

   Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.

   Z-1485-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Jan 24, 2023Class IIOpen, Classified

   An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

   Z-1351-2023 · Root cause: Process control · Recall details · FDA record ↗

4. Jan 20, 2022Class IIOpen, Classified

   Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

   Z-0813-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  A 72-year-old male patient was undergoing hemodialysis treatment via catheter with treatment initiated at approximately 6:30 AM. At approximately 7:44 AM, the patient experienced low blood pressure and vomiting, resulting in a code blue being called. Cardiopulmonary resuscitation (CPR) 5-10 compressions was performed as a medical intervention. Following the event, the patient's condition stabilized and the patient was alert. The treating team attributed the event to the patient's preexisting conditions. No alleged Tablo malfunction was reported or identified.

  Patient problems: Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 50863450 ↗
• MalfunctionSep 23, 2026Thermal Decomposition of Device

  It was reported that there was a low water pressure alarm and burning smell coming from the device during pre-treatment cycle. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863447 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient with a medical history of acute kidney injury (AKI) was undergoing hemodialysis treatment. Treatment was initiated at approximately 2:15 PM, at approximately 4:00 PM, the patient experienced cardiac arrest. A full-code resuscitation was performed, and the patient was successfully revived and subsequently intubated. No alleged Tablo malfunction was reported or identified.

  Patient problems: Cardiac Arrest

  MAUDE report 50863446 ↗
• MalfunctionSep 22, 2026Thermal Decomposition of Device

  It was reported that power cord had some dark marks. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849870 ↗
• MalfunctionSep 21, 2026Thermal Decomposition of Device

  Registered nurse (RN) called in to report console started smoking from the power cord connector. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846921 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Arrest

  MAUDE report 50831518 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Loss of consciousness

  MAUDE report 50831508 ↗
• MalfunctionSep 18, 2026Thermal Decomposition of Device

  The customer site reported power cord receptacle arcing and noticing a burning smell. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831492 ↗
• MalfunctionSep 17, 2026Thermal Decomposition of Device

  It was reported that a power cord was replaced during preventative maintenance (PM). No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812719 ↗
• MalfunctionSep 17, 2026Thermal Decomposition of Device

  It was reported that a power cord was replaced during preventative maintenance (PM). No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812718 ↗
• MalfunctionSep 17, 2026Thermal Decomposition of Device

  It was reported that the power entry module overheated due to loose connection. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812447 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  A registered nurse reported that a 45-year-old female patient with a reported poor prognosis experienced a cardiac arrest during hemodialysis treatment. A code was called at approximately 6:45 AM, and Cardiopulmonary resuscitation (CPR) was initiated. Despite resuscitative efforts, the patient could not be revived and expired. The treating team attributed the event to the patient's preexisting conditions. No alleged Tablo malfunction was reported or identified.

  Patient problems: Cardiac Arrest

  MAUDE report 50797154 ↗
• MalfunctionSep 15, 2026Thermal Decomposition of Device

  It was reported that there was a service required light on the TabloCart; the light was unable to be cleared with power cycling and Tablo was unable to complete cycles with continued low water pressure alarms. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779259 ↗
• DeathSep 9, 2026Adverse Event Without Identified Device or Use Problem

  A 64-year-old female patient with a medical history of diabetes mellitus, end-stage renal disease (ESRD), heart failure with reduced ejection fraction, aortic stenosis, and pulmonary hypertension underwent hemodialysis treatment. Treatment was initiated at 3:05PM, at approximately 3:13PM, the patient experienced a cardiac arrest. Cardiopulmonary resuscitation (CPR) was performed. Despite medical intervention, the patient expired. The treating team attributed the event to the patient's preexisting conditions. No alleged Tablo malfunction was reported or identified.

  Patient problems: Cardiac Arrest

  MAUDE report 50698917 ↗
• DeathSep 9, 2026Adverse Event Without Identified Device or Use Problem

  A 51-year-old male patient with diabetic ketoacidosis-hyperosmolar hyperglycemic state (DKA-HHS) and acute kidney injury (AKI) underwent dialysis treatment. Prior to treatment, the patient was unstable, intubated, and had high potassium levels. Treatment was initiated at approximately 2205. At 2238, the patient experienced a cardiac arrest. Medical interventions included cardiopulmonary resuscitation (CPR), and transfer to the intensive care unit (ICU). Despite resuscitative efforts, the patient expired. The treating team attributed the event to the patient's preexisting conditions. No alleged Tablo malfunction was reported or identified.

  Patient problems: Cardiac Arrest

  MAUDE report 50682268 ↗
• MalfunctionSep 9, 2026Thermal Decomposition of Device

  It was reported that the Tablo cart power cord was burnt and burn smell was coming from console during pre-treatment cycle. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680906 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 84-year-old male was receiving dialysis treatment via catheter access. Treatment was initiated at 1116 hours and at approximately 1201 hours the patient experienced a cardiac arrest. A full code was performed, and the patient's blood was returned. Following the event, the patient expired. The treating team attributed the event to the patient's preexisting conditions.

  Patient problems: Cardiac Arrest

  MAUDE report 50602404 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient coded at approximately 12 minutes after dialysis treatment start. Resuscitation efforts were initiated; however, the patient expired. The treating team attributed the event to the patient's pre-existing conditions.

  Patient problems: Insufficient Information

  MAUDE report 50602386 ↗
• MalfunctionSep 2, 2026Thermal Decomposition of Device

  It was reported that there was power cord thermal damage at the attachment point on the rear of the console during the pre-treatment cycle. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576252 ↗
• MalfunctionAug 28, 2026Thermal Decomposition of Device

  It was reported that there was burning smell coming from unit during heat cycle. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50503257 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  THE REGISTERED NURSE (RN) REPORTED THAT THE PATIENT'S VENOUS ACCESS BECAME DISLODGED DURING HEMODIALYSIS TREATMENT. UPON IDENTIFICATION OF THE DISLODGMENT, THE NURSE TERMINATED THE TREATMENT TO PREVENT FURTHER BLOOD LOSS. BLOOD WAS NOT RETURNED TO THE PATIENT, AND THE AMOUNT OF BLOOD LOSS IS UNKNOWN. RESUSCITATIVE MEASURES, INCLUDING CARDIOPULMONARY RESUSCITATION (CPR), ADMINISTRATION OF EPINEPHRINE, AND TRANSFUSION OF THREE UNITS OF BLOOD, WERE PERFORMED. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). NO ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE VENOUS ACCESS DISLODGEMENT OR THE PATIENT'S FINAL CLINICAL OUTCOME WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Loss of Vascular Access

  MAUDE report 25365769 ↗
• MalfunctionMar 5, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS AN ALARM FOR DIALYZER BLOOD LEAK TWO TIMES DURING TREATMENT. NURSE CONFIRMED POSITIVE BLOOD LEAK ALERT/ALARM THAT WAS VERIFIED AS POSITIVE WITH THE BLOOD LEAK TESTING STRIPS AT THE DIALYZER. APPROXIMATELY 600 ML OF BLOOD WAS LOST. NO PATIENT ADVERSE EVENT WAS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24525160 ↗
• MalfunctionMar 4, 2026No Apparent Adverse Event

  THE CALLER REPORTED THAT THE SALINE BAG RAN DRY APPROXIMATELY 45 MINUTES INTO TREATMENT, RESULTING IN AIR IN THE VENOUS BLOODLINE. THE USER ENDED THE TREATMENT AND WAS UNABLE TO RETURN THE PATIENT¿S BLOOD. THE CARTRIDGE AND SALINE BAG WERE REPLACED, AND TREATMENT WAS RESTARTED. DURING THE RESTART, THE PATIENT¿S ACCESS LINE CLOTTED, LEADING TO A SECOND INSTANCE OF BEING UNABLE TO RETURN THE PATIENT¿S BLOOD. APPROXIMATELY 480CC OF BLOOD WAS LOST. NO PATIENT ADVERSE EVENT WAS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24506795 ↗
• MalfunctionFeb 25, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS ALARM AIR IN VENOUS BLOOD LINE DURING PATIENT TREATMENT. APPROXIMATELY 480CC OF BLOOD WAS LOST. NO PATIENT ADVERSE EVENT WAS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24441502 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  AN (B)(6) MALE PATIENT WITH END-STAGE RENAL DISEASE ON PALLIATIVE CARE UNDERWENT HEMODIALYSIS. DURING TREATMENT, THE VENOUS NEEDLE BECAME DISLODGED, LEADING TO SIGNIFICANT BLOOD LOSS. THE PATIENT REMAINED ALERT AND ORIENTED BUT DEVELOPED HYPOTENSION SECONDARY TO EXSANGUINATION. MEDICAL STAFF INITIATED SALINE BOLUSES AND ADMINISTERED BLOOD TRANSFUSION. THE PATIENT WAS TRANSFERRED FROM THE MEDICAL-SURGICAL UNIT TO THE INTENSIVE CARE UNIT FOR FURTHER CARE. NO ALLEGED MALFUNCTION OF THE DEVICE WAS REPORTED. THE PATIENT EXPIRED THE FOLLOWING MORNING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Loss of Vascular Access

  MAUDE report 24316113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200741, K211370, K223248, K233335. One submission often covers many models, so check the product and lot details in each record.

• Z-2150-2024 · Apr 30, 2024 · Open, Classified
  TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used wit