Health Canada Flags Type I Recall of Abiomed Impella Controllers 2026

Health Canada has classified a recall of certain Automated Impella Controllers (AIC) made by Abiomed Inc. as Type I. The recall was initiated on 2026-09-25 and published on the Government of Canada recalls site on 2026-10-02 under identification number RA-82721. It is a voluntary medical device recall (removal) aimed at healthcare providers, not at the general public.

Ten specific controller units are listed in the Canadian notice. The issue involves design updates that were meant to be applied to some consoles but, according to the manufacturer, were not.

Products Affected by This Recall

The recall covers Automated Impella Controllers distributed under three model or catalogue numbers. Health Canada’s notice lists the following serial numbers:

• Model 0042-0040-CA: IC13503, IC13266, IC11171, IC11172
• Model 0042-0000-CA: IC1769, IC5821, IC5824, IC9416, IC9414
• Model 0042-0000-US: IC1179

The notice also states that not all units are affected by this issue. Facilities should compare the serial numbers on their consoles against the list above rather than assume every Impella controller is included.

What Triggered the Recall

The problem came to light through an internal check by the manufacturer. Abiomed carried out a retrospective review of its Field Change Notices (FCN) and found that certain AIC consoles in the field had not received the updates introduced by FCN 113. Those updates were previously rolled out through Abiomed’s field service process, which is why the company describes the recall as covering design changes already implemented elsewhere.

If the FCN 113 updates are missing, the console may behave incorrectly in two ways. The screen may freeze during the Purge Cassette Change Wizard, and the controller may display a false controller error.

The Health Risk

Health Canada has assigned the recall to Type I, the classification the agency uses for the most serious category of recalls. According to the notice, the defects could delay the initiation of support during device set-up.

In high-risk patient populations, this may lead to temporary inadequate hemodynamic support or a temporary loss of hemodynamic support. Hemodynamic support refers to assistance with blood circulation, which is the function the Impella system is used to provide in cardiovascular care. The notice does not report any injuries or deaths linked to the issue.

Who Should Be Concerned

The audience for this recall is healthcare. Hospitals and clinical teams that use Automated Impella Controllers should check their equipment against the model and serial numbers listed above. The notice classifies the product under cardiovascular medical devices and gives the issue type as medical devices performance.

The manufacturer is Abiomed Inc., based at 22 Cherry Hill Drive, Danvers, Massachusetts, United States. The Canadian notice does not specify which hospitals or provinces received the affected controllers.

What Healthcare Facilities Should Do

Health Canada’s guidance for this recall is brief. The listed action is to contact the manufacturer if additional information is required.

• Check each Automated Impella Controller against the serial numbers and model numbers in the notice.
• Contact Abiomed for further information about affected units and the FCN 113 updates.
• Continue to use hospital inventory where needed, because the notice says it may continue to be used to ensure continuity of care.

The notice does not describe a refund or replacement process, and it does not list direct contact details for the manufacturer. Facilities should reach out to Abiomed through their existing support channels.

Quick Facts

• Product: Automated Impella Controllers (AIC)
• Company: Abiomed Inc.
• Recall number: RA-82721
• Recall class: Type I
• Recall date: 2026-09-25
• Published: 2026-10-02
• Units listed: 10 serial numbers

From the Agency

Health Canada’s notice says Abiomed decided to initiate a voluntary medical device recall (removal) for design changes previously implemented through the field service process. It adds that failure to implement the applicable FCN 113 updates may cause the screen to freeze and display a false controller error. The agency also states that hospital inventory may continue to be used to ensure continuity of care.

Healthcare professionals and members of the public can report a health or safety concern to Health Canada through its online reporting service, and can subscribe to recall email notifications on the recalls and safety alerts website.