TabloCart™ with Prefiltration Drawer PN-0006813Recalls & reported problems
Outset Medical, Inc. · Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 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, 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
- Apr 30, 2024Class IIOpen, Classified
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.
Z-2150-2024 · Root cause: Device Design · Recall details · FDA record ↗
Other Subsystem, Water Purification devices
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- Ultrafilter U 9000 112062Gambro Dialysatoren GmbH · Subsystem, water purification6 reports
- Millenium HX RO,MILLENIUM HX,750GPD,115~,60HZMar Cor Purification, Inc. · Subsystem, Water Purification3 reports
- CWP RO,CWP,28LPM,104HMar Cor Purification, Inc. · Subsystem, Water Purification2 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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