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Impella Heart Pump recallZ-0069-2026 · Abiomed, Inc. · initiated Oct 1, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0069-2026
Status
Open, Classified
Initiated by the company
Oct 1, 2025
Posted by the FDA
Oct 9, 2025
Recalling firm
Abiomed, Inc.
Quantity
10,153 units
Product code
OZD
FDA submissions
P140003, P170011
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.

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; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

13 devices cleared under P140003, P170011 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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