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PRISMAFLEX TPE 2000 SET

GAMBRO INDUSTRIES · Model 114093 · UDI-DI 07332414111038

MDP Prescription

510(k) clearances

232

Adverse events (8 deaths)

Recalls

Facilities

Description

The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.

Recalls

Date	Firm	Reason
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2014-07-18	Gambro Renal Products, Incorporated	Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
2014-07-18	Gambro Renal Products, Incorporated	Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

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Data 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.