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Fluent Pro Waste Bag

Hologic, Inc. · Model FLT-205 · UDI-DI 25420045516110

HIH HIG Prescription

510(k) clearances

8,602

Adverse events (41 deaths)

Recalls

134

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
2026-05-21	Karl Storz Endoscopy	Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could
2025-11-11	Olympus Corporation of the Americas	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2024-04-18	Olympus Corporation of the Americas	The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2023-07-20	Olympus Corporation of the Americas	IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
2023-06-23	Scholly Fiberoptic Gmbh	There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occu
2022-06-07	Covidien Llc	Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

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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.