Impella Controller (Abiomed) – cybersecurity vulnerability (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 Controll
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Abiomed, Inc. is recalling Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following due to Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Recommended Action
Per FDA guidance
Abiomed notified consignees via UPS delivery on about 10/01/2025. Consignees were informed of the potential cybersecurity vulnerabilities related to network and physical access. Next steps included that product was not being removed, to maintain the affected device in a secure environment with restricted access, and an Abiomed field representative will contact consignees to arrange disabling the AIC's network capabilities. Consignees were instructed to review the notice and forward it to applicable personnel or customers if further distributed, report any suspicions of a cybersecurity event, and complete and return the response form. A follow up notification was sent to non-responding consignees on about 11/12/2025. The letter informed consignees that they were being contacted because they have not returned the response to the first notification. If a completed Business Reply Form is not received before a third notification letter (approximately 30 days), Abiomed will proactively disable remote viewing capabilities on Impella Connect.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026