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Health Canada Medical devices

Prismaflex Control Units

Issued January 20, 2026
Issue
Vantive is issuing an urgent medical device correction to all Prismaflex control unit users due to the potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex control unit, as shown in figure 3 below. This issue does not affect PrisMax control units and may occur only when the Prismaflex sets are being used with the Prismaflex control unit, as the two machines have different deaeration chamber holder designs.
Hazard description
Performance
Product
Product name
Prismaflex Control Units
Reference
ID
RA-81505