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PRISMAFLEX SET
Vantive Health GmbH · Model HF1000 · UDI-DI 07332414201265
KDI
Prescription
1
510(k) clearances
43,984
Adverse events (2,610 deaths)
217
Recalls
87
Facilities
Description
The Prismaflex HF1000 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
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.