| | Class 1 Device Recall Automated Impella Controller (AIC) |  |
| Date Initiated by Firm | October 01, 2025 |
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| Date Posted | October 09, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0069-2026 |
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| Recall Event ID |
97617 |
| PMA Number | P140003 P170011 |
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| Product Classification |
Temporary non-roller type left heart support blood pump - Product Code OZD
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| 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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| Code Information |
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. |
Recalling Firm/
Manufacturer |
Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
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| For Additional Information Contact | Morgaine Johnson
978-646-1400 |
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Manufacturer Reason
for Recall | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). |
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FDA Determined
Cause 2 | Software design |
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| Action | 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.
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| Quantity in Commerce | 10,153 units |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database | PMAs with Product Code = OZD
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