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Impella controller

Official notice

13 May 2026

Last checked

13 May 2026

Critical riskHealth Canada
Watch Abiomed

An official Health Canada notice concerns Impella controller. Abiomed, Inc. Has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used. Published 2026-05-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82061

Official notice

2026-05-13

The hazard

Abiomed, Inc. Has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used.

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-82061

Model Numbers

0042-0040-CA, 0042-0000-CA

Recall Numbers

82061

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Affected products

Product 1

Lot or serial number - Software V6.0.1–6.0.3 and ≥7.1, Model or catalogue number - 0042-0040-CA

Product 2

Lot or serial number - Software V6.0.1–6.0.3 and ≥7.1, Model or catalogue number - 0042-0000-CA

Risk / hazard

Abiomed, Inc. Has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used.

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

critical

Recall details

Recall number

82061

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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