{
  "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": "2026-04-29",
    "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": "98393",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 Cherry Hill Dr",
      "address_2": "",
      "postal_code": "01923-2575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International distribution in the country of Australia, Canada, France, Germany, Kuwait.",
      "recall_number": "Z-1591-2026",
      "product_description": "Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.    4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.",
      "product_quantity": "62 units",
      "reason_for_recall": "Potential that the \"Purge System Blocked\"  alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.",
      "recall_initiation_date": "20260216",
      "center_classification_date": "20260327",
      "report_date": "20260408",
      "code_info": "All products below with software version 8.2.2 through 8.5 are affected.  1. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416.   2. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581.  3. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312.  4. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140.  5. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683.   6. Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440.   7. Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894.   8. Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425.   9. Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.",
      "more_code_info": ""
    }
  ]
}