Insufflator, Hysteroscopic
FDA adverse event reports and recall history for insufflator, hysteroscopic (product code HIG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 539
- Deaths
- 12
- Injuries
- 87
- Malfunctions
- 433
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-12Open, ClassifiedProcess change control
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
Due to nonconforming products being inadvertently distributed.
- 2024-01-05Open, ClassifiedSoftware design
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload
- 2015-04-20TerminatedSoftware design
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
To correct software bugs that could affect the ability to accurately measure fluid deficit.
- 2007-11-07TerminatedDevice Design
Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.
- Open, ClassifiedSoftware design
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
- TerminatedNonconforming Material/Component
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Monitor insufflator, hysteroscopic automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.