Fluid management system control unit display freeze during hysteroscopic procedures
A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with documented software malfunction creating a risk of serious fluid overload complication (intra-vasation) during hysteroscopic surgery. No injuries or hospitalizations are reported in the source text, but the potential for patient harm from uncontrolled fluid administration is significant.
Plain-English summary
The Covidien HysteroLux Fluid Management System Control Unit (REF: 72205000) is a device used in hysteroscopic surgical procedures to monitor and manage fluid administration to the uterus. The device has a software defect affecting how it tracks and displays fluid volumes.
When the inflow volume reaches 32,450 ml, the device display will freeze because an internal software calculation threshold is exceeded. During this freeze, the outflow measurement continues to function, but the system's overall fluid balance tracking becomes unreliable. The accumulated fluid deficit begins counting backwards toward zero instead of continuing accurate measurement.
This malfunction creates a risk that distention fluid may reach the soft tissue circulatory system, a serious complication in hysteroscopic surgery. Approximately 1,100 units are affected, identified by specific serial numbers, and were distributed nationwide.
Patients and healthcare providers should contact WOM World of Medicine AG to determine if their device is affected and to obtain repair or replacement instructions.
The recalled product
- Product
- Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
- Manufacturer
- WOM World of Medicine AG
- Affected units
- 1,100
Distribution
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