FDA-Device2025-08-06Class I
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 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, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product
Hazard
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Sold states
Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Affected count
11,031 units
Manufactured in
24 Cherry Hill Dr, Danvers, MA, United States
Products
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 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, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2164-2025More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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