Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding
Summary
The FDA issued a Class I for Automated Impella Controller (AIC), used for left heart support blood pump, labe by Abiomed, Inc.. Reason: Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC)..
Details
Source
Device Recall
External ID
Z-0069-2026
Action Date
2025-10-15
Status
Ongoing
Category
device
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.
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.
Quantity Affected: 10,153 units
Reason for Recall
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-01
Company
Danvers, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 161 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0069-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29