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Prismaflex control units

Official notice

20 Jan 2026

Last checked

20 Jan 2026

Medium riskHealth Canada

An official Health Canada notice concerns Prismaflex control units. 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. Published 2026-01-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81505

Official notice

2026-01-20

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

107636, 973003, PRISMAFLEX HF1000, 107140, PRISMAFLEX ST150 SET, 107640, 107144, PRISMAFLEX TPE 2000

Other

RA RA-81505

Model Numbers

107636, 973003, PRISMAFLEX HF1000, 107140, PRISMAFLEX ST150 SET, 107640, 107144, PRISMAFLEX TPE 2000

Recall Numbers

81505

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Affected products

Product 1

Lot or serial number - All lots., Model or catalogue number - 107636

Product 2

Lot or serial number - All lots., Model or catalogue number - 973003

Product 3

Lot or serial number - All lots., Model or catalogue number - PRISMAFLEX HF1000

Product 4

Lot or serial number - All lots., Model or catalogue number - 107140

Product 5

Lot or serial number - All lots., Model or catalogue number - PRISMAFLEX ST150 SET

Product 6

Lot or serial number - All lots., Model or catalogue number - 107640

Product 7

Lot or serial number - All lots., Model or catalogue number - 107144

Product 8

Lot or serial number - All lots., Model or catalogue number - PRISMAFLEX TPE 2000

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Vantive Health.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81505

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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