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TabloCart™ with Prefiltration Drawer
Outset Medical, Inc. · Model PN-0006988 · UDI-DI 00850001011297
1
510(k) clearances
43,764
Adverse events (2,589 deaths)
217
Recalls
87
Facilities
Description
Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-30 | Fresenius Medical Care Renal Therapies Group, LLC | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis ma |
| 2026-05-11 | Fresenius Medical Care Holdings, Inc. | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2025-10-27 | Nipro Medical Corporation | Screw may loosen or fallout of Hemodialysis system |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.