Health Canada Classifies Abiomed Automated Impella Controller Recall as Type I
Health Canada has classified the recall of 10 specified Abiomed Automated Impella Controllers as Type I after a retrospective review found that the affected consoles had not received FCN 113 updates intended to prevent screen freezing and false controller errors during the Purge Cassette Change Wizard.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Health Canada lists a Type I recall of specified Automated Impella Controllers that missed FCN 113 design updates. The affected units may experience screen freezing and a false controller error during the Purge Cassette Change Wizard.
MedTech Current analysis
Why it matters
A failure during setup can delay initiation of circulatory support. In high-risk patients, this may lead to temporary inadequate or lost hemodynamic support. The notice permits continued use of hospital inventory to maintain continuity of care and states that not all controllers are affected.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisAffected healthcare organizationsCompare controller serial numbers with the affected list and coordinate the applicable FCN 113 update with Abiomed; the public notice does not specify an update schedule.
Official recall information
Official actions
According to Health Canada:
- Hospital inventory may continue to be used to ensure continuity of care.
- Contact the manufacturer if additional information is needed.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Abiomed initiated a voluntary medical device recall involving 10 Automated Impella® Controllers in Canada. A retrospective review of Field Change Notices found that these consoles had not received the design updates introduced through FCN 113. Health Canada classifies the recall as Type I.
According to the Health Canada notice, failure to implement the applicable FCN 113 updates may cause the screen to freeze during the Purge Cassette Change Wizard and may generate a false controller error. These defects can delay initiation of circulatory support during device setup and, in high-risk patient populations, may lead to temporary inadequate hemodynamic support or a temporary loss of hemodynamic support.
Health Canada states that not all Automated Impella Controllers are affected and that hospital inventory may continue to be used to ensure continuity of care. The notice categorizes the issue as a medical-device performance recall for a healthcare audience.
Who and what are affected
The recall applies to 10 identified Automated Impella Controllers across three catalogue numbers:
| Model / catalogue number | Affected serial numbers |
|---|---|
| 0042-0040-CA | IC13503, IC13266, IC11171, IC11172 |
| 0042-0000-CA | IC1769, IC5821, IC5824, IC9416, IC9414 |
| 0042-0000-US | IC1179 |
Health Canada identifies Abiomed Inc. as the company responsible for the recall. The recall date is September 25, 2026, and Health Canada published the notice on October 2 under identification number RA-82721.
The affected consoles are part of the Automated Impella Controller platform used to operate Impella percutaneous ventricular assist devices. The issue is limited to specified units identified through Abiomed’s retrospective field-service review.
What affected organizations should do
Affected healthcare organizations
According to the Health Canada notice:
- Hospital inventory may continue to be used to ensure continuity of care.
- Contact the manufacturer if additional information is needed.
MedTech Current analysis — Affected healthcare organizations: Check controller serial numbers against the affected list and coordinate the applicable FCN 113 update with Abiomed. These are preparation steps based on the identified units and missed updates; the public notice does not set out a separate update schedule.
Health Canada does not state that all AIC inventory should be removed from clinical use while the update is being coordinated.