INFINITY Fluid Management Accessory FG-0204Recalls & reported problems
Minerva Surgical, Inc. · Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850033976236), received between May 23, 2025 and May 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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
- Off-Label Use1
- Use of Device Problem1
Patient problems
- Uterine Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem
IT WAS REPORTED THAT A PATIENT TOOK ON APPROXIMATELY 3100ML OF FLUID AND WAS ADMITTED TO THE ICU. STAFF CALLED THE MINERVA REPRESENTATIVE AFTER A SECOND BAG WAS ADDED TO SYSTEM IN CONFLICT WITH THE PRESCRIBED LABELING. THE MINERVA REPRESENTATIVE INSTRUCTED THEM TO ACCOUNT FOR ALL FLUID OUTSIDE OF THE PATIENT AND STOP THE PROCEDURE IMMEDIATELY. ACCORDING TO THE TREATING RESIDENT, A PERFORATION WAS REPAIRED LAPAROSCOPICALLY AND THE PATIENT WAS SENT TO THE ICU OVERNIGHT FOR OBSERVATION. THERE WAS NO REPORTS OF SYMPTOMS RELATED TO FLUID OVERLOAD OR ANY ADDITIONAL MEDICAL INTERVENTION. PATIENT STATUS IS UNKNOWN BUT REPORTEDLY THE PATIENT WAS SCHEDULED TO BE RELEASED THE NEXT DAY.
Patient problems: Uterine Perforation
MAUDE report 22077165 ↗
Other Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar devices
- Symphion FG-0202Boston Scientific Corporation · Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar1 death38 reports
- Symphion FG-0201Boston Scientific Corporation · Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar1 death13 reports
- Symphion Resecting Device FG-0201Minerva Surgical, Inc. · Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar9 reports
- Symphion FG-0612-RBoston Scientific Corporation · Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar7 reports
- Symphion FG-0612Boston Scientific Corporation · Insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar1 report
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.
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