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Z-0069-2026Class I

Abiomed, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Abiomed, Inc.
Product type
Device
Status
Ongoing
Report date
2025-10-15
Distribution
Nationwide distribution. International distribution to United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Colombia, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom of Great Britain and Northern Ireland, Greece, Hong Kong, Croatia, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan.
Firm state
MA
Product quantity
10,153 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data Integrity
Reason for recall

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Product description

Automated Impella Controller (AIC), used for 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, 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, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP;

Code / lot info

1. Product Code: 0042-0000-AU; GTIN: 813502010886; All Serial Numbers. 2. Product Code: 0042-0000-CA; GTIN: 813502011272; All Serial Numbers. 3. Product Code: 0042-0000-EU; GTIN: 813502011289; All Serial Numbers. 4. Product Code: 0042-0000-EU-L; GTIN: 813502011289; All Serial Numbers. 5. Product Code: 0042-0000-IN; GTIN: 813502011418; All Serial Numbers. 6. Product Code: 0042-0000-JP; GTIN: 813502010428; All Serial Numbers. 7. Product Code: 0042-0000-JP-L; GTIN: 813502010428; All Serial Numbers. 8. Product Code: 0042-0000-UK; GTIN: 813502011296; All Serial Numbers. 9. Product Code: 0042-0000-UK-L; GTIN: 813502011296; All Serial Numbers. 10. Product Code: 0042-0000-US; GTIN: 813502010022; All Serial Numbers. 11. Product Code: 0042-0000-US-L; GTIN: 813502010022; All Serial Numbers. 12. Product Code: 0042-0010-AU; GTIN: 813502010930; All Serial Numbers. 13. Product Code: 0042-0010-EU; GTIN: 813502010961; All Serial Numbers. 14. Product Code: 0042-0010-EU-L; GTIN: 813502010961; All Serial Numbers. 15. Product Code: 0042-0010-IN; GTIN: 813502011425; All Serial Numbers. 16. Product Code: 0042-0010-UK; GTIN: 813502010978; All Serial Numbers. 17. Product Code: 0042-0010-UK-L; GTIN: 813502010978; All Serial Numbers. 18. Product Code: 0042-0010-US; GTIN: 813502010985; All Serial Numbers. 19. Product Code: 0042-0010-US-L; GTIN: 813502010985; All Serial Numbers. 20. Product Code: 0042-0040-AU; GTIN: 813502012972; All Serial Numbers. 21. Product Code: 0042-0040-CA; GTIN: 813502012958; All Serial Numbers. 22. Product Code: 0042-0040-CT; GTIN: 813502011722; All Serial Numbers. 23. Product Code: 0042-0040-CT-L; GTIN: 813502011722; All Serial Numbers. 24. Product Code: 0042-0040-EU; GTIN: 813502012217; All Serial Numbers. 25. Product Code: 0042-0040-EU-L; GTIN: 813502012217; All Serial Numbers. 26. Product Code: 0042-0040-JP; GTIN: 813502011814; All Serial Numbers. 27. Product Code: 0042-0040-JP-L; GTIN: 813502011814; All Serial Numbers. 28. Product Code: 0042-0040-UK; GTIN: 813502012484; All Serial Numbers. 29. Product Code: 0042-0040-US; GTIN: 813502011401; All Serial Numbers. 30. Product Code: 0042-0040-US-L; GTIN: 813502011401; All Serial Numbers. 31. Product Code: 1000201; GTIN: 813502010442; All Serial Numbers. 32. Product Code: 1000432; GTIN: 813502013030; All Serial Numbers.

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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →