Fluent Pro Fluid Management System FLT-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045516212), received between Jan 14, 2025 and Jun 19, 2026 — classified as 1 death, 4 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE AND FLUENT PROCEDURE ON (B)(6)2026, THAT THE UTERUS WAS SET AND HOLDING TO 80 MMHG PRESSURE AND THE DEFICIT WAS NORMAL. DURING RESECTION OF A LARGE POLYP, THE DEFICIT INCREASED AND THE FLUENT SYSTEM WAS EXTREMELY LOUD. THE UTERUS HOLDING PRESSURE STARTED TO GO DOWN TO AROUND 60-70 MMHG. HIGH FLUID LOSS ALERT SHOWED UP ON THE SCREEN. THE PHYSICIAN NOTED NO VISIBLE FLUID LEAKAGE EXTERNALLY OR FROM THE CERVIX, AND ONLY A SMALL AMOUNT OF FLUID AROUND 200 ML WAS OBSERVED VIA ULTRASOUND PRESENT IN THE ABDOMEN. THE PHYSICIAN WENT BACK WITH THE SCOPE AND THE SAME ISSUE OCCURRED WHERE THE HIGH FLUID LOSS ERROR OCCURRED AD THE DEFICIT WAS SHOOTING UP. THE PHYSICIAN WENT BACK INTO THE CAVITY INSIDE WITH THE SCOPE AND THE MACHINE WAS QUIETER BUT DEFICIT WAS STILL RISING. HOWEVER, THE FLUID DEFICIT CONTINUED TO INCREASE AND HIGH FLUID LOSS ALARMS PRESISTED. DUE TO THE RECCURRENCE OF THE ISSUE AND CONCERN FOR A POSSIBLE UTERINE PERFORATION, THE PHYSICIAN ELECTED TO PERFORM LAPAROSCOPIC EVALUATION. A SECOND PHYSICIAN INSERTED A HYSTEROSCOPE WHILE LAPAROSCOPIC VISUALIZATION AND PERFORMED TO ASSESS FOR PERFORATION. NO VISIBLE UTERINE PERFORATION WAS IDENTIFIED, AND

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25567155 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE REACH AND FLUENT PRO ON (B)(6) 2026, THE PATIENT WENT INTO CARDIAC ARREST AND HAD TO BE RESUSCITATED. PATIENT HAD A PREVIOUS HISTORY OF RETAINED PRODUCTS OF CONCEPTION AND ADDITIONALLY HAD BEEN ADMITTED TO THE HOSPITAL OVER THE WEEKEND DUE TO SEPSIS FOLLOWING 2 SUCTION DILATATION AND CURETTAGE THE PREVIOUS WEEKEND. 5 MINUTES INTO THE PROCEDURE WHILE BEING UNDER ANESTHESIA THE PATIENT HAD SUDDEN DESATURATION AND CARDIOVASCULAR COLLAPSE. THE TEAM WAS ABLE TO SUCCESSFULLY RESUSCITATE AND STABILIZE THE PATIENT. THE DEFICIT AT THE TIME OF THE CARDIOVASCULAR COLLAPSE WAS READING 3065 ML WITH STAFF ESTIMATING APPROXIMATELY 1000 ML OF SPILLAGE ON THE FLOOR. WHEN THE PATIENT WENT INTO CARDIAC ARREST THE PATIENT LACKED PULSE AND OXYGEN FOR ONE MINUTE. DURING THE PROCEDURE THE PATIENT´S OXYGEN SATURATION DROPPED TO 30%, PROMPTING THE ANESTHESIOLOGIST TO CALL FOR A CRASH CART. TO ACCOMMODATE THE EMERGENCY EQUIPMENT THE FLUENT PROCEDURE WAS ENDED, PUSHED AWAY FROM THE PATIENT. AN ABDOMINAL ULTRASOUND WAS PERFORMED BY A NON-SCRUBBED SURGEON WHICH REVEALED NO INTERNAL FLUID ACCUMULATION. AT THE TIME TOTAL FLUID READ AT 5845 ML. CUTTING TIME WAS 4 MINUTES AND

  Patient problems: Cardiac Arrest; Pulmonary Embolism; Sepsis

  MAUDE report 25446816 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A MYOSURE XL PROCEDURE ON (B)(6) 2026, LATER IT WAS REPORTED THAT PATIENT DEVELOPED PULMONARY EDEMA ON (B)(6) 2026. PATIENT WAS DOING WELL BUT HAD TO BE ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION AND THE PATIENT RECEIVED LASIX (FUROSEMIDE/DIURETIC) 40 MG AS TREATMENT. ADDITIONAL INFORMATION REVEALED THAT THE FINAL FLUID DURING THE PROCEDURE WAS 2450 ML, NORMAL SALINE WAS USED DURING THE PROCEDURE. IT WAS CONFIRMED THAT NO SUSPECTED PERFORATION OCCURRED AND THAT THE PATIENT DIDN´T HAVE PRIOR MEDICAL DISORDERS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pulmonary Edema

  MAUDE report 25445536 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2025, THE DEFICIT WAS INCREASING RAPIDLY. ALTHOUGH THE PRESSURE WAS CONSTANT AT ABOUT 80 MMHG, THE PERCEPTION IS THAT IT MIGHT HAVE BEEN HIGHER. THE PATIENT SUFFERED FROM BRADYCARDIA AND FOR A MOMENT THE PULSE WAS LOST. WHEN THE TEAM PROCEEDED TO EXECUTE THE REANIMATION PROTOCOL, THE TUBING RUPTURED FROM THE CARTRIDGES AND CAUSED THE FLUID TO LEAK OUT OF THE CIRCUIT AND THE TUBING WAS AGITATING VIGOROUSLY. THE PATIENT WAS REANIMATED. AFTER HAVING THE PATIENT STABILIZED, A LEAK WAS DISCOVERED AT THE PATIENT'S BED SIDE AND WAS COMING FROM THE DISTAL END OF THE SCOPE. ABOUT 500 ML OF FLUIDS WAS OBSERVED. THE DRAPE WITH INTEGRATED DRAINAGE POCKET WAS BEING USED. ABNORMAL SOUNDS WERE ALSO REPORTED FOR A WEEK FROM THE PUMP. THE SYSTEM USED IN LATER CASES WORKED NORMALLY WITHOUT ANY ISSUES APART FROM THE FOOT PEDAL DIFFICULT TO OPERATE. THE PRESSURE SEEMED WAY HIGHER DURING THE CASE IN THE PATIENT THAN WHAT SHOWED ON THE PUMP. LIQUID WAS SPELLING ALL OVER THE PLACE. THE FLOW PACK BROKE DUE TO PRESSURE AND THE IRRIGATION TUBING DETACHED AT THE BOTTOM OF THE FLOW PACK AND SPILLED EVERYWHERE. PATIENT BRADYCARDIA DROPPED AROUND 20 BEATS PER

  Patient problems: Bradycardia

  MAUDE report 23556434 ↗
• DeathJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE/MYOSURE PROCEDURE ON DECEMBER (B)(6) 2024. INITIALLY THE PHYSICIAN RESECTED A FIBROID WITH THE FLUENT PRO. THE PHYSICIAN WAS ABLE TO RESECT THE FIBROID AND ALMOST HIT THE 2500 DEFICIT LIMIT. MYOSURE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PHYSICIAN PERFORMED A NOVASURE PROCEDURE WITH A SUCCESSFUL ABLATION. THE PATIENT WAS DISCHARGED AT THE TIME AND APPEARED FINE. 2 DAYS LATER THE PHYSICIAN WAS EXAMINING THE PATHOLOGY SAMPLES AND NOTED THAT THE PATIENT HAD DECEASED DUE TO A CARDIAC ARREST ON (B)(6) 2024. NO OTHER INFORMATION IS AVAILABLE, MULTIPLE ATTEMPTS AT OBTAINING INFORMATION WERE NOT RESPONDED.

  Patient problems: Cardiac Arrest

  MAUDE report 21152540 ↗