Tablo(R) CartridgeRecalls & reported problems across all models
Outset Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 3 models of Tablo(R) Cartridge by Outset Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2022 and Sep 22, 2026 — classified as 5 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (68 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. 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
Most reported Tablo(R) Cartridge problems
Device problems
- Fluid/Blood Leak68
- Defective Alarm1
- Disconnection1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Material Separation1
- Obstruction of Flow1
- Temperature Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding64
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Cough1
- Loss of consciousness1
- Low Blood Pressure/ Hypotension1
Tablo(R) Cartridge models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tablo(R) Cartridge PN-0006887Set, Tubing, Blood, With And Without Anti-Regurgitation Valve63 reports
- Tablo(R) Cartridge PN-0005643Set, Tubing, Blood, With And Without Anti-Regurgitation Valve5 reports
- Tablo(R) Cartridge PN-0008544Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 reports
Recent Tablo(R) Cartridge adverse event reports
The 15 most recent reports across all models, 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 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page