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Automated impella controller

Official notice

25 Feb 2026

Last checked

25 Feb 2026

High riskHealth Canada
Watch Abiomed

An official Health Canada notice concerns Automated impella controller. Abiomed has identified that Automated Impella Controller (AICS) with software V8.2.3, when used in conjunction with an Impella 5.5 with smart assist set (product code 0550-0004), has a delayed "purge system blocked" alarm. Software versions post-v10.1 have this issue addressed. Abiomed recommends that you do not use the AIC with an Impella 5.5 with smart assist set (product code 0550-0004) unless AIC software is updated to v10.1 or above. Published 2026-02-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81652

Official notice

2026-02-25

The hazard

Abiomed has identified that Automated Impella Controller (AICS) with software V8.2.3, when used in conjunction with an Impella 5.5 with smart assist set (product code 0550-0004), has a delayed "purge system blocked" alarm. Software versions post-v10.1 have this issue addressed. Abiomed recommends that you do not use the AIC with an Impella 5.5 with smart assist set (product code 0550-0004) unless AIC software is updated to v10.1 or above.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Skus

0042-0040-CA, 0042-0000-CA

Other

RA RA-81652

Model Numbers

0042-0040-CA, 0042-0000-CA

Recall Numbers

81652

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Affected products

Product 1

Lot or serial number - Software version 8.2.3, Model or catalogue number - 0042-0040-CA

Product 2

Lot or serial number - Software version 8.2.3, Model or catalogue number - 0042-0000-CA

Risk / hazard

Abiomed has identified that Automated Impella Controller (AICS) with software V8.2.3, when used in conjunction with an Impella 5.5 with smart assist set (product code 0550-0004), has a delayed "purge system blocked" alarm. Software versions post-v10.1 have this issue addressed. Abiomed recommends that you do not use the AIC with an Impella 5.5 with smart assist set (product code 0550-0004) unless AIC software is updated to v10.1 or above.

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Abiomed

Manufacturer

Not provided

Phone

Not provided

Brand: Abiomed.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

81652

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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