Public recall detail

Automated Impella® Controller

2025-10-23

medium
Recall Safety notice
Quick summary

Quick summary: Automated Impella® Controller. Date: 2025-10-23.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Automated Impella® Controller. Date: 2025-10-23.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbiomed Inc.
ProductAutomated Impella® Controller
IssueMedical devices - Performance
Recall classType II
IdentificationRA-78358

Affected products

ProductAutomated Impella® Controller
LotMore than 10 numbers, contact manufacturer.
Model0042-0040-CA
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAutomated Impella® Controller
ProductAutomated Impella® Controller
LotMore than 10 numbers, contact manufacturer.
Model0042-0000-CA
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAutomated Impella® Controller

Issue

Abiomed initiated a voluntary medical device recall (correction) to notify customers of identified cybersecurity vulnerabilities related to the operating system in the Automated Impella® Controller (AIC) that have residual risk related to network and physical access that could be compromised and that result in uncontrolled risks affecting the AIC operating system. Product is not being removed, and hospital inventory can continue to be used.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Recall date2025-10-14
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-78358
Background{}
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
AudiencesHealthcare
Source updated2025-10-23

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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