Tablo(R) Hemodialysis SystemRecalls & reported problems across all models
Outset Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Tablo(R) Hemodialysis System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 129
- Deaths reported
- 42
- Injuries reported
- 71
- Recalls
- 4
We found 2 models of Tablo(R) Hemodialysis System by Outset Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 129 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2019 and Sep 26, 2026 — classified as 42 deaths, 71 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (13 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
Reports received per month, all models
Tablo(R) Hemodialysis System 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.
- Aug 1, 2024Open, 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 · names 2 of these models · Recall details · FDA record ↗
- Mar 6, 2024Open, 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 · names 2 of these models · Recall details · FDA record ↗
- Jan 24, 2023Open, 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 ↗
- Jan 20, 2022Open, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Tablo(R) Hemodialysis System problems
Device problems
- Adverse Event Without Identified Device or Use Problem96
- Thermal Decomposition of Device13
- Fluid/Blood Leak5
- Air/Gas in Device3
- Calibration Problem3
- No Apparent Adverse Event3
- Use of Device Problem2
- Decreased Sensitivity1
Patient problems
- Hemorrhage/Blood Loss/Bleeding26
- Death24
- Loss of consciousness23
- Cardiac Arrest16
- No Clinical Signs, Symptoms or Conditions16
- Low Blood Pressure/ Hypotension11
- Blood Loss10
- Insufficient Information4
Tablo(R) Hemodialysis System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tablo(R) Hemodialysis System PN-0006000Dialyzer, High Permeability With Or Without Sealed Dialysate System4 recalls8 deaths46 reports
- Tablo(R) Hemodialysis System PN-0003000Subsystem, Water Purification3 recalls34 deaths83 reports
Recent Tablo(R) Hemodialysis System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Thermal Decomposition of Device
It was reported that there was a burnt power cord during idle mode. No patient was involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906572 ↗DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that 2 hours and 38 minutes into dialysis treatment, the treatment was ended due to patient's drop in blood pressure and code team was called. Cardiopulmonary resuscitation (CPR) was initiated, 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: Low Blood Pressure/ Hypotension
MAUDE report 50893047 ↗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 ↗
Other Outset Medical, Inc. products
All Outset Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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