Public recall detail

Automated Impella Controller

2026-02-25

medium
Cardiovascular Performance
Quick summary

Quick summary: Automated Impella Controller. Reason: Performance. Category: Cardiovascular. Date: 2026-02-25.

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. Reason: Performance. Category: Cardiovascular. Date: 2026-02-25.

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 I
IdentificationRA-81652

Affected products

ProductAutomated Impella Controller
LotSoftware version 8.2.3
Model0042-0040-CA
Serial numberSoftware version 8.2.3
DescriptionAutomated Impella Controller
ProductAutomated Impella Controller
LotSoftware version 8.2.3
Model0042-0000-CA
Serial numberSoftware version 8.2.3
DescriptionAutomated Impella Controller

Issue

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.

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 date2026-02-20
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-81652
Background{}
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
AudiencesHealthcare
Source updated2026-02-25

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

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