Fluent Console FLT-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15420045508552), received between Oct 3, 2019 and Feb 16, 2026 — classified as 1 death, 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THE PATIENT HAD ¨DIFFERENT¨ ANATOMY AND CALLED A PARTNER AS WELL AS AN ULTRASOUND TECH TO ASSIST. ABLATION WAS COMPLETED AND A HYSTEROSCOPY USING A FLUENT AND OMNI SCOPE WAS PERFORMED PRE AND POST ABLATION WITH NO ISSUES TO NOTE NOR INCREASE IN DEFICIT WITH THE FLUENT MACHINE. PATIENT DID NOT HAD AN ENDOMETRIAL BIOPSY PRIOR PROCEDURE SO THE PHYSICIAN PERFORMED A DILATION AND CURETTAGE IN THE OPERATING ROOM. PATHOLOGY CAME BACK WITH RESULTS AS ACUTE CHRONIC INFLAMMATION. ON (B)(6) THE PATIENT COMPLAINED OF ABDOMINAL PAIN FOR WHICH DIFFERENT MEDICATIONS WERE GIVEN AT THE TIME. ON (B)(6) 2026 THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN AND CONFUSION. LACTATE WAS 6.7 AND BLOOD PRESSURE PER HOSPITAL WAS ¨38/15¨. PATIENT RECEIVED AN EXPLORATORY LAPAROSCOPY AND WHEN THE TROCARS WERE INSERTED PUSS WAS OOZING AND THE ABDOMEN OF THE PATIENT WAS FULL OF PUSS. NO THERMAL INJURY WAS OBSERVED AND A SPOT IN THE CORNUAL AREA WAS OBSERVED TO HAVE FAT PRESSED AGAINST THE UTERUS. PATIENT WAS TOO DELICATE TO PERFORM A HYSTERECTOMY AND WAS INTUBATED AND BROUGHT TO THE ICU ON ANTIBIOT

  Patient problems: Abdominal Pain; Cardiogenic Shock; Sepsis; Septic Shock

  MAUDE report 24348927 ↗
• InjuryMay 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A FLUENT SYSTEM ON (B)(6) 2025, A MAXIMUM DEFICIT OF 2500ML WAS REACHED. THE NURSE, UNKNOWN TO THE SURGEON, ZEROED THE DEFICIT AND THE PROCEDURE CONTINUED. WHEN THE PROCEDURE WAS COMPLETED, A MANUAL DEFICIT SHOWED THAT THE DEFICIT WAS 5000ML. PATIENT WAS SENT TO THE PACU, WHO MADE SURE SHE COULD EMPTY HER BLADDER. PATIENT WAS DISCHARGED WITH NO FOLLOW UP TREATMENT OR MEDICATION GIVEN.

  Patient problems: Hypervolemia

  MAUDE report 21964128 ↗
• InjuryDec 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2024, DURING A FLUENT PROCEDURE, IT WAS REPORTED THAT DURING THE PROCEDURE THE FLUENT ALARM ACTIVATED SEVERAL TIMES THAT THE FLUID DEFICIT LIMIT WAS REACHED BUT WAS OVER-RIDDEN SEVERAL TIMES AFTER THE 2500 ML LIMIT. NO ISSUES WERE REPORTED WITH THE MACHINED AND THE PHYSICIAN WAS THE ONE WHO CHOOSE TO CANCEL THE ALARMS AND TO CONTINUE THE PROCEDURE. THE DEFICIT WAS SHOWING AN APPROXIMATE 5L DEFICIT. PATIENT EXHIBITED SYMPTOMS RELATED TO FLUID OVERLOAD AND THE PATIENT HAD TO BE TRANSFERRED TO THE INTENSIVE CARE UNIT FOR 24 HOURS.

  Patient problems: Hypervolemia

  MAUDE report 21019685 ↗
• InjuryJan 25, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2024, THE PHYSICIAN RESECTED A FIBROID AND EXCEEDED THE DEFICIT LIMIT OF 2500 ML 3 TIMES. IT WAS REPORTED THAT THE DEFICIT WAS MET 3 TIMES AND, EACH TIME, A MANUAL COUNT WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT HAD TO BE TAKEN TO THE INTENSIVE CARE UNIT. THE FINAL MANUAL COUNT WAS REPORTED AT 5000 ML. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypervolemia

  MAUDE report 18579384 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2023, THE FLUID DEFICIT STAYED AT A CERTAIN NUMBER DURING THE PROCEDURE AND THE STAFF DID NOT REALIZE IT , THUS THE PATIENT RECEIVED A FLUID OVERLOAD ESTIMATED AT AROUND 2 LITERS. PATIENT BECAME UNSTABLE DUE TO BRONCHOSPASM AND AFTER THE SURGERY PRESENTED WITH COUGH. DUE THE PATIENT EXHIBITING SYMPTOMS OF FLUID OVERLOAD IT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND RECEIVED A CHEST X-RAY AND TREATMENT WITH STEROIDS AND DIURETICS. THE PATIENT WAS DISCHARGED AFTER SEVERAL DAYS AND IS RECOVERING WELL. THE CONSOLE WAS EXAMINED AND TESTED AND IT WAS FOUND WITHIN TOLERANCE LIMIT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bronchospasm; Hypervolemia

  MAUDE report 18092013 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2022 WHILE USING THE FLUID MANAGEMENT SYSTEM (FLUENT), THE PHYSICIAN NOTICED THAT THE FLOW RATE WAS HIGH WHEN AT 80 MMHG; HE THEN DECIDED TO DECREASE THE INTRA UTERINE PRESSURE TO 60 MMHG. SUDDENLY, THE TISSUE TRAP OF THE FLUENT SYSTEM EXPLODED, DUE TO THE PRESSURE OF THE SALINE SOLUTION. AT THE SAME TIME, THE PATIENT'S BLOOD PRESSURE DROPPED; THE PH DID DROP AS WELL (AROUND 6 ¿ ACIDOSIS) AND HER BODY TEMPERATURE AT 34C. THE ANESTHESIOLOGIST SUSPECTED A PULMONARY EMBOLISM BUT WAS DISCARDED. NO INJURIES RELATED TO HYPERVOLEMIA AND FLUID OVERLOAD WERE REPORTED AND THE PATIENT WAS KEPT IN OBSERVATION , THE PATIENT DID RECOVER BY THAT AFTERNOON, AND NO OTHER ADVERSE EVENTS WERE NOTED: NO NEUROLOGICAL DISORDER OBSERVED. THE PATIENT WAS HOSPITALIZED FOR ONE NIGHT UNDER OBSERVATION. THE NEXT DAY, SHE WAS BETTER AND RETURNED BACK HOME. THE PATIENT DID NOT REQUIRE ADDITIONAL TREATMENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042476 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), AFTER A FLUENT PROCEDURE THE PATIENT HAD TO BE KEPT IN OBSERVATION DUE TO POSSIBLE FLUID OVERLOAD. THE PATIENT EVOLVED WELL AND WAS DISCHARGED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypervolemia

  MAUDE report 14175685 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOMECTOMY THAT INVOLVED A FLUENT ON JULY 16TH, DURING THE PROCEDURE THE DEFICIT JUMPED TO 5000 AND THE STAFF HAD TO PERFORM A MANUAL COUNT. THE PROCEDURE WAS COMPLETED AND AT THE END OF THE PROCEDURE THE MANUAL COUNT WAS 2500 ML. THE PATIENT HAD TO BE READMITTED TO THE HOSPITAL AFTER THE SURGERY DUE TO A PULMONARY EDEMA. NO OTHER INFORMATION IS AVAILABLE

  Patient problems: Pulmonary Edema

  MAUDE report 12308626 ↗
• InjuryJul 6, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON JUNE 17TH DURING A FLUENT PROCEDURE, THE FLUID DEFICIT QUICKLY AUGMENTED REACHING A DEFICIT OF 2500 ML, THE FLUENT CONSOLE STOPPED THE INFLOW AND ALERTED THE PHYSICIAN ABOUT REACHING THE LIMIT FOR 2500 ML, THEN THE PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE BY RESETTING THE FLUID DEFICIT TO ZERO. AFTER THE PROCEDURE, THE PATIENT WAS LOW ON OXYGEN AND PRESENTED WITH FLUID IN HER LUNGS AND BLOOD IN HER URINE WHICH PROMPTED THE STAFF TO ADMIT HER TO THE EMERGENCY ROOM. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypervolemia; Pulmonary Edema; Unspecified Kidney or Urinary Problem

  MAUDE report 12124368 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A FLUENT PROCEDURE THAT INVOLVED A PATIENT WHO HAD RETAINED PRODUCTS OF CONCEPTION THE PHYSICIAN HAD TO PERFORM A HYSTERECTOMY ON THE PATIENT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Incomplete Induced Abortion

  MAUDE report 12088984 ↗
• MalfunctionFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JANUARY 18TH, DURING A FLUENT PROCEDURE THE OUT-FLOPAK BROKE APART ON 3 OCCASIONS. NO INJURIES TO THE PATIENT OR STAFF WERE REPORTED AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11352442 ↗
• DeathOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 28TH DOCTOR PERFORMED A MYOSURE LITE PROCEDURE ON AN (B)(6) PATIENT WHO HAS HIGH BLOOD PRESSURE AND WAS POST MENOPAUSAL PATIENT TO OBTAIN SOME SAMPLES. THE DEFICIT DID NOT EXCEED 100 ON THE SYSTEM AND THE TECHS DID NOT DO A MANUAL COUNT. TWO DAYS LATER THE PATIENT PASSED AWAY FROM A PULMONARY EMBOLISM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 10759216 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, FOUR TIMES WHEN AN 800 ML FLUID DEFICIT WAS REACHED, THE MACHINE ALARMED AND ZEROED OUT THE DEVICE. PROCEDURE CARRIED ON ALL FOUR TIMES. AFTER THE FOURTH TIME, THEY SET THE DEFICIT LIMIT TO 2500 ML. THE ALARM SOUNDED ONCE 2500 ML WAS REACHED, AND THE DEVICE WAS ZEROED OUT AGAIN AND THE PROCEDURE CONTINUED. THE WASTE BAG FILLED UP. A NON-HOLOGIC DEVICE WAS USED TO SUCTION OUT THE FLUID. SIX 3 L BAGS WERE USED. THEY ATTEMPTED TO USE THIS INFORMATION TO OBTAIN A MANUAL COUNT. THE FINAL TOTAL DEFICIT WAS 9,800 ML. THE PATIENT WAS BROUGHT TO THE ICU FOLLOWING THE PROCEDURE. SHE HAD INTERSTITIAL SWELLING OF THE FACE AND SWELLING OF THE TONGUE. SHE WAS RELEASED FROM THE HOSPITAL A DAY AFTER THE PROCEDURE.

  Patient problems: Hypervolemia

  MAUDE report 9153882 ↗