Aquilex Fluid Control System

WOM has received complaints from customers in the United States that the display of inflow volume on the Aquilex Fluid Control System can reach its limit of 30,000 ml during long procedures. In these cases, the display does not indicate the actual inflow volume. In cases where an unusually high amount of fluid is used for distension of the patient's uterus, the calculation of the inflow and outflow volumes reaches its limit and the pump control unit display will freeze at the maximum value. There is a risk of distension fluid reaching the circulatory system of the patient's soft tissue.

Recall start date: July 17, 2023