Fluent Fluid Management System FLT-112SRecalls & reported problems
Hologic, Inc. · The Fluent® 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 fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Hologic Fluent fluid management system has 140 adverse event reports, with no deaths and 2 injuries. Most describe disposable parts cracking or breaking apart during use, along with suction failures and parts that would not register. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 140
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 15420045507401), received between Mar 12, 2019 and Mar 20, 2026 — classified as 2 injuries, 138 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (118 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation118
- Leak/Splash7
- Detachment of Device or Device Component3
- Material Rupture3
- Material Separation3
- Adverse Event Without Identified Device or Use Problem1
- Burst Container or Vessel1
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions130
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hypervolemia1
Recent adverse event reports
The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Failure to Obtain Sample; Separation Problem
IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2026, THE CASE AROUND THE TISSUE SOCK OPENED DUE TO PRESSURE BUILT UP AND THE SPECIMEN FELL ONTO THE FLOOR. TISSUE WAS LOST BUT ENOUGH TISSUE COULD BE RETRIEVED FOR A SAMPLE. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24650236 ↗MalfunctionOct 27, 2025Suction Failure
FROM STAFF: FLUENT TUBING FOR MYOSURE DEVICE WAS NOT WORKING. MYOSURE MACHINE WAS MALFUNCTIONING IN THAT SUCTION FUNCTION WAS NOT WORKING. RN SOUGHT HELP FROM (B)(6) CHARGE WHO CALLED REP FOR MACHINE, ADVISED CHANGING TUBING AND KEEPING MALFUNCTIONING TUBING FOR FURTHER INVESTIGATION. TUBING SUCTION NOT WORKING, DID NOT EVACUATE CAVITY WHILE SCOPE PROCEDURE WAS BEING DONE. PROCEDURE WAS COMPLETED AFTER NEW TUBING WAS ATTACHED. REF NUMBER FOR TUBING FLT-112S, LOT 25G02RA EXP DATE 7/1/28.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389744 ↗MalfunctionJul 17, 2025Communication or Transmission Problem
THE TEAM WENT TO PLUG DISPOSABLE PART INTO THE MACHINE, BLUE PART PLUGGED IN AND REGISTERED. WHEN YELLOW PART WAS PLUGGED IN, IT WOULD NOT REGISTER. NO PART OF PRODUCT TOUCHED OR WAS USED ON PATIENT. CONTINUED WITH NEW PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530078 ↗MalfunctionMar 5, 2025
FLUENT FLUID MANAGEMENT SYSTEM MALFUNCTIONED PRIOR TO PATIENT ARRIVING INTO THE OPERATING ROOM. HEALTHCARE PROVIDER HAD TO OPEN A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21525206 ↗MalfunctionMay 4, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6), THE OUT-FLOPAK CRACKED DURING THE INITIAL PRIME CYCLE OF THE CONSOLE. NO HARM TO THE PATIENT OR STAFF REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14282452 ↗MalfunctionMar 30, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON (B)(6) 2022 DURING A FLUENT PROCEDURE , THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13952012 ↗MalfunctionMar 30, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT IN (B)(6) 2022, DURING A FLUENT PROCEDURE , THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13951597 ↗MalfunctionMar 30, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON (B)(6) 2022 DURING A FLUENT PROCEDURE , THE OUT-FLOPAK BROKE APART DURING THE PRIMING. NO PATIENT OR STAFF INJURIES REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13951582 ↗MalfunctionMar 30, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON (B)(6) 2022 DURING A FLUENT PROCEDURE, THE OUT-FLOPAK BROKE APART DURING THE PRIMING. NO PATIENT OR STAFF INJURIES REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13951575 ↗MalfunctionMar 29, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE, THE OUT-FLOPACK HOUSING BROKE APART IN PIECES. NO INJURIES TO THE PATIENT OR STAFF WERE REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13943400 ↗MalfunctionMar 24, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022 THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13871486 ↗MalfunctionMar 23, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022 THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13871197 ↗MalfunctionMar 23, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022 THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13871073 ↗MalfunctionMar 23, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON FEBRUARY 24TH , THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO INJURY TO THE STAFF OR PATIENT REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13871031 ↗MalfunctionMar 23, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON MARCH 3RD DURING A FLUENT PROCEDURE THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13870743 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FLUENT PROCEDURE THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636279 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2021 , THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636267 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022, THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636260 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022, THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636254 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FLUENT PROCEDURE THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636251 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON AN UNKNOWN DATE, THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636250 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022, THE OUT-FLOPAK BROKE APART DURING THE PRIMING. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636249 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FLUENT PROCEDURE THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636244 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022 , THE OUT-FLOPAK BROKE APART DURING THE PRIMING. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636241 ↗MalfunctionMar 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON AN UNKNOWN DATE , DURING A FLUENT PROCEDURE THE OUT-FLOPAK BROKE APART DURING THE PROCEDURE. NO PATIENT OR STAFF INJURY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636218 ↗
Other INSUFFLATOR, HYSTEROSCOPIC devices
- Aquilex® Fluid Control System AQL-100CBSW.O.M. World of Medicine GmbH · Insufflator, Hysteroscopic1 recall18 reports
- Aquilex Fluid Control System AQL-100PBSW.O.M. World of Medicine GmbH · Insufflator, Hysteroscopic1 recall8 reports
- ENDOMAT UP210Karl Storz GmbH & Co. KG · Insufflator, hysteroscopic4 deaths15 reports
- Aquilex® Fluid Control System AQL-100CSW.O.M. World of Medicine GmbH · Insufflator, Hysteroscopic15 reports
- Fluent Console FLT-100Hologic, Inc. · INSUFFLATOR, HYSTEROSCOPIC1 death13 reports
- Hysteroscopic Fluid Management System Stand 7210165Smith & Nephew, Inc. · INSUFFLATOR, HYSTEROSCOPIC9 reports
- HysteroLux™ Fluid Management System Control Unit PH304W.O.M. World of Medicine GmbH · Insufflator, Hysteroscopic6 reports
- Hysteroscopic Fluid Management 7210164Smith & Nephew, Inc. · INSUFFLATOR, HYSTEROSCOPIC6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page