Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart supp

Recalled 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 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.

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code 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.

✅ What Should You Do?

1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart supp

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