CFIA - Canadian Food Inspection Agency
CFIA - Canadian Food Inspection Agency
10/02/2026 | Press release | Distributed by Public on 10/02/2026 09:38
Automated Impella Controllers (AIC)
Health product recall
Automated Impella® Controllers (AIC)
Brand(s)
Last updated
2026-10-02
Summary
Product
Automated Impella® Controllers (AIC)
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
|
Affected products |
Lot or serial number |
Model or catalogue number |
|
Automated Impella® Controllers (AIC) |
IC13503 |
0042-0040-CA |
|
Automated Impella® Controllers (AIC) |
IC13266 |
0042-0040-CA |
|
Automated Impella® Controllers (AIC) |
IC11171 |
0042-0040-CA |
|
Automated Impella® Controllers (AIC) |
IC11172 |
0042-0040-CA |
|
Automated Impella® Controllers (AIC) |
IC1769 |
0042-0000-CA |
|
Automated Impella® Controllers (AIC) |
IC5821 |
0042-0000-CA |
|
Automated Impella® Controllers (AIC) |
IC5824 |
0042-0000-CA |
|
Automated Impella® Controllers (AIC) |
IC9416 |
0042-0000-CA |
|
Automated Impella® Controllers (AIC) |
IC9414 |
0042-0000-CA |
|
Automated Impella® Controllers (AIC) |
IC1179 |
0042-0000-US |
Issue
Abiomed has decided to initiate a voluntary medical device recall (removal) for design changes that were previously implemented through the Abiomed field service process. Abiomed performed a retrospective review of Field Change Notices (FCN) and determined that certain AIC consoles in the field did not receive the updates introduced by FCN 113.
Failure to implement the applicable FCN 113 updates may result in the screen freezing during the Purge Cassette Change Wizard and the display of a false controller error.
These defects could delay the initiation of support during device set-up and, in high-risk patient populations, may lead to temporary inadequate hemodynamic support or a temporary loss of hemodynamic support. Hospital inventory may continue to be used to ensure continuity of care. Not all units are affected by this issue.
Additional information
Details
Original published date: 2026-10-02
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Recall date
2026-09-25
Identification number
RA-82721
Get notified
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Date modified: 2026-10-02
CFIA - Canadian Food Inspection Agency published this content on October 02, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on October 02, 2026 at 15:38 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]