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Fluent Pro Procedure Kit

Hologic, Inc. · Model FLT-212S · UDI-DI 15420045516144

HIG HIH Prescription

510(k) clearances

541

Adverse events (12 deaths)

Recalls

Facilities

Description

The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation liquid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators.

Recalls

Date	Firm	Reason
2026-04-09	Stryker Corporation	Due to nonconforming products being inadvertently distributed.
2023-07-17	WOM World Of Medicine AG	The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start coun
2021-06-18	WOM World of Medicine AG	When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold i
2019-08-14	WOM World of Medicine AG	The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
2014-09-01	Thermedx LLC	To correct software bugs that could affect the ability to accurately measure fluid deficit.
2007-08-17	Karl Storz Endoscopy America Inc	Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.

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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.