Public recall detail

Impella Controller

2026-05-13

medium
Cardiovascular Performance
Quick summary

Quick summary: Impella Controller. Reason: Performance. Category: Cardiovascular. Date: 2026-05-13.

Recommended action

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

Recall details

Quick summary: Impella Controller. Reason: Performance. Category: Cardiovascular. Date: 2026-05-13.

Official details

Affected product details

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

BrandAbiomed Inc.
ProductImpella Controller
IssueMedical devices - Performance
Recall classType I
IdentificationRA-82061

Affected products

ProductImpella Controller
LotSoftware V6.0.1–6.0.3 and ≥7.1
Model0042-0040-CA
Serial numberSoftware V6.0.1–6.0.3 and ≥7.1
DescriptionImpella Controller
ProductImpella Controller
LotSoftware V6.0.1–6.0.3 and ≥7.1
Model0042-0000-CA
Serial numberSoftware V6.0.1–6.0.3 and ≥7.1
DescriptionImpella Controller

Issue

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.

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 date2026-05-11
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-82061
Background{}
CompaniesAbiomed Inc. 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
AudiencesHealthcare
Source updated2026-05-13

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

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