{
  "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": "2026-08-05",
    "results": {
      "skip": 7000,
      "limit": 1,
      "total": 39677
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Danvers",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97440",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 Cherry Hill Dr",
      "address_2": "N/A",
      "postal_code": "01923-2575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX.  International distribution to Canada, Germany, Great Britian, Italy, Netherlands, Norway.",
      "recall_number": "Z-2568-2025",
      "product_description": "Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump.   1. Impella Controller, Packaged, US; Product Code: 0042-0000-US.  2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L.   3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.   4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.  5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.   6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.",
      "product_quantity": "71 units",
      "reason_for_recall": "Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.",
      "recall_initiation_date": "20250820",
      "center_classification_date": "20250919",
      "report_date": "20251001",
      "code_info": "1. Product Code: 0042-0000-US; GTIN: 813502010022; Serial Numbers: IC1026, IC1029, IC1043, IC1046, IC1040, IC1047, IC1088, IC1089, IC1093, IC1110, IC1167, IC1221, IC1225, IC1222, IC1258, IC1250, IC1272, IC1293, IC1320, IC1317, IC1353, IC1354, IC1355, IC1375, IC1377, IC1403, IC1446, IC1450, IC1452, IC1461, IC1496, IC1501, IC1508, IC1515, IC1516, IC1517, IC1518, IC1530, IC1534, IC1535, IC1539, IC1538, IC1531, IC1533, IC1540, IC1532, IC1551, IC1552, IC1550, IC1553, IC1646, IC1756, IC2255, IC2422, IC2489, IC3013.  2. Product Code: 0042-0000-US-L; GTIN: 813502010022; Serial Number: IC1281.   3. Product Code: 0042-0000-CA; GTIN: 813502011272; Serial Numbers: IC1543, IC1544.   4. Product Code: 0042-0000-EU; GTIN: 813502011289; Serial Numbers: IC1350, IC1383, IC1546, IC1548, IC1547, IC1549, IC1775, IC2243, IC4002.  5. Product Code: 0042-0000-UK; GTIN: 813502011296; Serial Numbers: IC1519, IC1542.   6. Product Code: 0042-0000-UK-L; GTIN: 813502011296; Serial Number: IC1493.",
      "more_code_info": ""
    }
  ]
}