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REVACLEAR
Gambro Dialysatoren GmbH · Model Revaclear 400 · UDI-DI 07332414126209
KDI
Prescription
10
510(k) clearances
43,984
Adverse events (2,610 deaths)
217
Recalls
87
Facilities
Description
Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis.
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.