Health Canada2 Oct 2026
Automated Impella® Controllers (AIC)
Health Canada published a recall notice for Automated Impella® Controllers (AIC) on 2 Oct 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 2 Oct 2026
- Recall type
- Health product recall
- Companies
- Abiomed Inc. · 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
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 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
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.