{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Danvers",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97617",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 Cherry Hill Dr",
      "address_2": "",
      "postal_code": "01923-2575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-0069-2026",
      "product_description": "Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes:  1.\tImpella Controller, Packaged, AU; Product Code: 0042-0000-AU.   2.\tImpella Controller, Packaged, CA; Product Code: 0042-0000-CA.   3.\tImpella Controller, Packaged, EU; Product Code: 0042-0000-EU.   4.\tImpella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L.   5.\tImpella Controller, Packaged, IN; Product Code: 0042-0000-IN.   6.\tImpella Controller, Packaged, JP; Product Code: 0042-0000-JP.   7.\tImpella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L.   8.\tImpella Controller, Packaged, UK; Product Code: 0042-0000-UK.   9.\tImpella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.   10.\tImpella Controller, Packaged, US; Product Code: 0042-0000-US.   11.\tImpella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L.   12.\tImpella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU.   13.\tImpella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.   14.\tImpella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L.   15.\tImpella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN.   16.\tImpella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.   17.\tImpella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L.   18.\tImpella Optical Controller, Packaged, US; Product Code: 0042-0010-US.   19.\tImpella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L.   20.\tOptical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.   21.\tOptical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA.   22.\tAIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT.   23.\tAIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L.   24.\tOptical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU.   25.\tOptical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L.   26.\tOptical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP.   27.\tOptical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L.   28.\tOptical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK.   29.\tOptical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.   30.\tOptical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L.   31.\tDbl optical, AIC Impella Connect, Phg US; Product Code: 1000201.   32.\tAIC w/Impella Connect for ECP; Product Code: 1000432.",
      "product_quantity": "10,153 units",
      "reason_for_recall": "Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).",
      "recall_initiation_date": "20251001",
      "center_classification_date": "20251009",
      "report_date": "20251015",
      "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.",
      "more_code_info": ""
    }
  ]
}