{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "216119",
      "product_res_number": "Z-0069-2026",
      "event_date_initiated": "2025-10-01",
      "event_date_posted": "2025-10-09",
      "recall_status": "Open, Classified",
      "res_event_number": "97617",
      "product_code": "OZD",
      "pma_numbers": [
        "P140003",
        "P170011"
      ],
      "product_description": "Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes:\n\n1.\tImpella Controller, Packaged, AU; Product Code: 0042-0000-AU. \n\n2.\tImpella Controller, Packaged, CA; Product Code: 0042-0000-CA. \n\n3.\tImpella Controller, Packaged, EU; Product Code: 0042-0000-EU. \n\n4.\tImpella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. \n\n5.\tImpella Controller, Packaged, IN; Product Code: 0042-0000-IN. \n\n6.\tImpella Controller, Packaged, JP; Product Code: 0042-0000-JP. \n\n7.\tImpella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. \n\n8.\tImpella Controller, Packaged, UK; Product Code: 0042-0000-UK. \n\n9.\tImpella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. \n\n10.\tImpella Controller, Packaged, US; Product Code: 0042-0000-US. \n\n11.\tImpella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. \n\n12.\tImpella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. \n\n13.\tImpella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. \n\n14.\tImpella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. \n\n15.\tImpella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. \n\n16.\tImpella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. \n\n17.\tImpella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. \n\n18.\tImpella Optical Controller, Packaged, US; Product Code: 0042-0010-US. \n\n19.\tImpella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. \n\n20.\tOptical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. \n\n21.\tOptical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. \n\n22.\tAIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. \n\n23.\tAIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. \n\n24.\tOptical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. \n\n25.\tOptical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. \n\n26.\tOptical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. \n\n27.\tOptical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. \n\n28.\tOptical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. \n\n29.\tOptical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. \n\n30.\tOptical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. \n\n31.\tDbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. \n\n32.\tAIC w/Impella Connect for ECP; Product Code: 1000432.",
      "code_info": "1. Product Code: 0042-0000-AU; GTIN: 813502010886; All Serial Numbers. \n\n2. Product Code: 0042-0000-CA; GTIN: 813502011272; All Serial Numbers.  \n\n3. Product Code: 0042-0000-EU; GTIN: 813502011289; All Serial Numbers.  \n\n4. Product Code: 0042-0000-EU-L; GTIN: 813502011289; All Serial Numbers.  \n\n5. Product Code: 0042-0000-IN; GTIN: 813502011418; All Serial Numbers.  \n\n6. Product Code: 0042-0000-JP; GTIN: 813502010428; All Serial Numbers.  \n\n7. Product Code: 0042-0000-JP-L; GTIN: 813502010428; All Serial Numbers.  \n\n8. Product Code: 0042-0000-UK; GTIN: 813502011296; All Serial Numbers.  \n\n9. Product Code: 0042-0000-UK-L; GTIN: 813502011296; All Serial Numbers.  \n\n10. Product Code: 0042-0000-US; GTIN: 813502010022; All Serial Numbers.  \n\n11. Product Code: 0042-0000-US-L; GTIN: 813502010022; All Serial Numbers.  \n\n12. Product Code: 0042-0010-AU; GTIN: 813502010930; All Serial Numbers.  \n\n13. Product Code: 0042-0010-EU; GTIN: 813502010961; All Serial Numbers.  \n\n14. Product Code: 0042-0010-EU-L; GTIN: 813502010961; All Serial Numbers.  \n\n15. Product Code: 0042-0010-IN; GTIN: 813502011425; All Serial Numbers.  \n\n16. Product Code: 0042-0010-UK; GTIN: 813502010978; All Serial Numbers.  \n\n17. Product Code: 0042-0010-UK-L; GTIN: 813502010978; All Serial Numbers.  \n\n18. Product Code: 0042-0010-US; GTIN: 813502010985; All Serial Numbers.  \n\n19. Product Code: 0042-0010-US-L; GTIN: 813502010985; All Serial Numbers.  \n\n20. Product Code: 0042-0040-AU; GTIN: 813502012972; All Serial Numbers.  \n\n21. Product Code: 0042-0040-CA; GTIN: 813502012958; All Serial Numbers.  \n\n22. Product Code: 0042-0040-CT; GTIN: 813502011722; All Serial Numbers.  \n\n23. Product Code: 0042-0040-CT-L; GTIN: 813502011722; All Serial Numbers.  \n\n24. Product Code: 0042-0040-EU; GTIN: 813502012217; All Serial Numbers.  \n\n25. Product Code: 0042-0040-EU-L; GTIN: 813502012217; All Serial Numbers.  \n\n26. Product Code: 0042-0040-JP; GTIN: 813502011814; All Serial Numbers.  \n\n27. Product Code: 0042-0040-JP-L; GTIN: 813502011814; All Serial Numbers.  \n\n28. Product Code: 0042-0040-UK; GTIN: 813502012484; All Serial Numbers.  \n\n29. Product Code: 0042-0040-US; GTIN: 813502011401; All Serial Numbers.  \n\n30. Product Code: 0042-0040-US-L; GTIN: 813502011401; All Serial Numbers.  \n\n31. Product Code: 1000201; GTIN: 813502010442; All Serial Numbers.  \n\n32. Product Code: 1000432; GTIN: 813502013030; All Serial Numbers.",
      "firm_fei_number": "1220648",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 Cherry Hill Dr",
      "city": "Danvers",
      "state": "MA",
      "postal_code": "01923-2575",
      "additional_info_contact": "Morgaine Johnson\n978-646-1400",
      "reason_for_recall": "Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).",
      "root_cause_description": "Software design",
      "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.\n\nA 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.",
      "product_quantity": "10,153 units",
      "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.",
      "openfda": {
        "pma_number": [
          "P140003"
        ],
        "registration_number": [
          "1220648",
          "2528981",
          "3007904765"
        ],
        "fei_number": [
          "1220648",
          "2528981",
          "3007904765"
        ],
        "device_name": "Temporary Non-Roller Type Left Heart Support Blood Pump",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}