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Automated impella® controller

Official notice

28 Apr 2026

Last checked

28 Apr 2026

Critical riskHealth Canada
Watch Abiomed

An official Health Canada notice concerns Automated impella® controller. Abiomed, Inc. Has initiated a voluntary medical device recall (removal) of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). A retrospective review of servicing records identified that certain AIC units require specific hardware updates to address potential safety concerns. These updates are intended to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death. Published 2026-04-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81986

Official notice

2026-04-28

The hazard

Abiomed, Inc. Has initiated a voluntary medical device recall (removal) of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). A retrospective review of servicing records identified that certain AIC units require specific hardware updates to address potential safety concerns. These updates are intended to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death.

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.

Lots

IC2369, IC2370, IC1572, IC2686, CI1665, IC1544, IC2687

Skus

0042-0000-CA

Other

RA RA-81986

Model Numbers

0042-0000-CA

Recall Numbers

81986

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Affected products

Product 1

Lot or serial number - IC2369, Model or catalogue number - 0042-0000-CA

Product 2

Lot or serial number - IC2370, Model or catalogue number - 0042-0000-CA

Product 3

Lot or serial number - IC1572, Model or catalogue number - 0042-0000-CA

Product 4

Lot or serial number - IC2686, Model or catalogue number - 0042-0000-CA

Product 5

Lot or serial number - CI1665, Model or catalogue number - 0042-0000-CA

Product 6

Lot or serial number - IC1544, Model or catalogue number - 0042-0000-CA

Product 7

Lot or serial number - IC2687, Model or catalogue number - 0042-0000-CA

Risk / hazard

Abiomed, Inc. Has initiated a voluntary medical device recall (removal) of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). A retrospective review of servicing records identified that certain AIC units require specific hardware updates to address potential safety concerns. These updates are intended to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death.

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

81986

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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