Tablo(R) Cartridge PN-0006887Recalls & reported problems
Outset Medical, Inc. · Tablo X Cartridge, OMM · Class 2
All models of Tablo(R) Cartridge (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Outset Medical Tablo X cartridge is a single-use blood tubing set used with the Tablo X machine. The 62 reports filed in the past 12 months mostly describe blood or fluid leaking from the cartridge, and one describes a cartridge coming apart during treatment; patients are reported to have bleeding, with one injury. There were no deaths and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00850001011259), received between Dec 22, 2025 and Sep 22, 2026 — classified as 1 injury, 62 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (62 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak62
Patient problems
- Hemorrhage/Blood Loss/Bleeding63
- Loss of consciousness1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that there was blood leaking from the backside of the cartridge during patient treatment. There was estimated 100 mL blood loss. No patient adverse event was noted as a result of this event.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50849869 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that there was blood leaking from the cartridge behind the blood pump area during patient treatment. An estimated 300mL of blood was lost. No patient adverse event was noted as a result of this event.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50849868 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50812454 ↗MalfunctionAug 18, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50306238 ↗MalfunctionAug 16, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50267259 ↗MalfunctionAug 16, 2026Fluid/Blood Leak
It was reported that there was a cartridge rupture during patient treatment. There was estimated 5mL blood loss. No patient adverse event was noted as a result of this event.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50263520 ↗MalfunctionAug 14, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50261468 ↗MalfunctionAug 14, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50247671 ↗MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50233462 ↗MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50233460 ↗MalfunctionAug 12, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50226092 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50117137 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50109764 ↗MalfunctionJul 28, 2026
It was reported that the arterial pod on the cartridge broke and got stuck on the Tablo during patient treatment. There was an estimate of 25-50 mL blood loss. No patient adverse event was noted as a result of this event.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50054005 ↗MalfunctionJul 27, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50045943 ↗MalfunctionJul 20, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25882770 ↗MalfunctionJul 17, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25864661 ↗MalfunctionJul 17, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25864657 ↗MalfunctionJul 15, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25822354 ↗MalfunctionJul 13, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25808402 ↗MalfunctionJul 13, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25808137 ↗MalfunctionJul 9, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25774289 ↗MalfunctionJul 9, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25757955 ↗MalfunctionJul 8, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25747506 ↗MalfunctionJun 25, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A BLOOD LEAKING FROM BLOOD PUMP SEGMENT OF CARTRIDGE DURING PATIENT TREATMENT. AN ESTIMATE OF 20ML OF BLOOD WAS LOST. NO PATIENT ADVERSE EVENT WAS NOTED AS A RESULT OF THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25620198 ↗
Other Set, Tubing, Blood, With And Without Anti-Regurgitation Valve devices
- Hemodialysis Bloodlines SL-2010M2096B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve3 recalls3 deaths1,000 reports
- Hemodialysis Bloodlines SL-2010M2096AB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death483 reports
- Hemodialysis Bloodlines SL-2000M2095DAB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death214 reports
- CombiSet 03-2722-9Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE8 deaths311 reports
- Hemodialysis Bloodlines SL-2000M2095B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall219 reports
- CombiSet 03-2522-1Fresenius Medical Care Holdings, Inc. · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve1 recall214 reports
- Cartridge Blood Set 101025Gambro Renal Products, S.A. de C.V. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE3 recalls80 reports
- Hemodialysis Bloodlines SL-2000M2095DB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall158 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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