BEUDAMED
    FDA Recall Open, Classified

    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

    Recall: Z-2360-2026 · Initiated May 14, 2026

    Recall

    Recall Number
    Z-2360-2026
    Event Number
    98853
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 14, 2026
    Posted
    June 12, 2026
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

    Reason

    Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

    Action

    Abiomed notified consignees on about 05/14/2026 via letter titled "URGENT MEDICAL DEVICE RECALL (CORRECTION)." Consignees were made aware of the issue and potential risk and were informed that devices were not being removed, and hospital inventory can continue to be used. Specific, outlined scenarios were explained and that if they were to occur, that a console exchange is unnecessary as the phenomenon will recur on the exchange device. Abiomed is actively working on a software update to the AIC to address this issue. Consignees were instructed to complete and return the provided business reply form, forward the notice to anyone in each facility that needs to be informed, post copy of the notice in a visible area for awareness, and if any affected products have been forwarded to another facility, contact that facility and provide them with the notice.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.

    Quantity

    10,297 units