FDA-Device2026-06-24Class IPROCESSING DEFECT
Abiomed Impella Controller recalled for software error risk
What this means
A software error in certain Automated Impella Controller devices (used to manage left heart support blood pumps) may affect device function. The error affects controllers with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above across multiple regions worldwide.
- If you operate or maintain an Impella Controller system, check your device's serial number and software version against the recall notice.
- Contact Abiomed directly for instructions on software updates or device replacement.
- Do not discontinue use of the device without medical guidance from your healthcare provider.
The agency's original wording
Hazard
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
10,297 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2360-2026More Abiomed recalls
- FDA-Device2026-07-22Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
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