Recall MonitorHealth Products
Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
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
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets | 253304 | AVA 500 MPAT |
| Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets | 252602 | AVA 500 MPAT |
Issue
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.