Product Wiki · Recalls · Health Canada — Medical Devices

HysteroLux Fluid Management System (2020-11-23) — recall 61901

Health Canada — Medical Devices · Canada · 2020-12-11 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
61901
Date of alert
2020-12-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: WOM has received complaints from customers in the United States that the display of inflow volume on the HysteroLux Fluid Management System can reach its limit of 32,450 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. Our investigation has identified a software anomaly as the cause for this display freeze. The reason for this is that at 32,450 mL an internal software calculation threshold is being reached. As the outflow measurement will continue, the result is that the deficit accumulated up to this point will start counting backwards until 0 mL is reached.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hysterolux-fluid-management-sy

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.