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Health Canada Health products

Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets

Issued April 24, 2026
Issue
Product Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
In April 2025, an off-the-shelf stopcock used in the Avanta Multi-Patient Administration Tube sets (AVA 500 MPAT (part 2 of 2)) was revised by the supplier to achieve ISO 80369-7 compliance and ensure connectability to other connectors. These changes resulted in a fit issue with the CFCV interface on the Avanta injector system. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the Contrast Flow Control Valve (CFCV) snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
Reference
ID
RA-82073