FDA-Device2026-06-03Class IPROCESSING DEFECT

Abiomed Impella Controller recalled for alarm failures and cassette misalignment

ELECTRICAL SHOCKOTHERNationwide distribution

Abiomed Impella Controller recalled for electrical and alignment faults

Certain Impella Controller (AIC) consoles contain electrical faults including alarm failures, power-path problems, and inaccurate motor sensing. Additionally, improper alignment between the purge cassette and motor drive can prevent the purge system from priming correctly, requiring users to switch to a backup console.

Check if your Impella Controller serial number matches the recalled list provided by Abiomed
Contact your Abiomed representative or device supplier for inspection or replacement
Ensure a backup AIC console is available if your unit is affected

Hazard

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.

Sold states

Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.

Affected count

625 units

Manufactured in

22 Cherry Hill Dr, Danvers, MA, United States

Products

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2026

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