Aquilex Fluid Control System May Cause Fluid Overload During Hysteroscopy
The Aquilex Fluid Control System (Models AQL-100PBS, AQL-100P) display may freeze at maximum volume (30,000 ml) during long procedures, causing inaccurate fluid monitoring and potential fluid overload.
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 recall involving a risk-of-harm device. The display malfunction may result in fluid overload during hysteroscopy, a serious potential complication, but no injuries or hospitalizations have been reported.
Plain-English summary
The Aquilex Fluid Control System (Models AQL-100PBS and AQL-100P), manufactured by WOM World Of Medicine AG, is being recalled due to a display malfunction during hysteroscopy procedures.
The system is intended to monitor fluid volume during diagnostic and operative hysteroscopies. During extended procedures, the inflow volume display can reach its maximum limit of 30,000 ml. When this occurs, the display freezes at the maximum value while the deficit counter begins counting backwards toward zero. This malfunction prevents accurate fluid monitoring and may result in fluid overload.
1,287 units have been distributed in the United States and internationally, including Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, United Kingdom, Kuwait, Qatar, Turkey, and United Arab Emirates. Affected units can be identified by serial numbers listed in the FDA recall notice.
The recalled product
- Product
- 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
- Manufacturer
- WOM World Of Medicine AG
- Affected units
- 1,287
Distribution
Distributed nationwide across the United States.
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