Official recall record
Prismaflex Control Units
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-01-20
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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