{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215604",
      "product_res_number": "Z-2568-2025",
      "event_date_initiated": "2025-08-20",
      "event_date_posted": "2025-09-19",
      "recall_status": "Open, Classified",
      "res_event_number": "97440",
      "product_code": "OZD",
      "product_description": "Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. \n\n1. Impella Controller, Packaged, US; Product Code: 0042-0000-US.\n\n2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. \n\n3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. \n\n4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.\n\n5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. \n\n6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.",
      "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.\n\n2. Product Code: 0042-0000-US-L; GTIN: 813502010022; Serial Number: IC1281. \n\n3. Product Code: 0042-0000-CA; GTIN: 813502011272; Serial Numbers: IC1543, IC1544. \n\n4. Product Code: 0042-0000-EU; GTIN: 813502011289; Serial Numbers: IC1350, IC1383, IC1546, IC1548, IC1547, IC1549, IC1775, IC2243, IC4002.\n\n5. Product Code: 0042-0000-UK; GTIN: 813502011296; Serial Numbers: IC1519, IC1542. \n\n6. Product Code: 0042-0000-UK-L; GTIN: 813502011296; Serial Number: IC1493.",
      "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": "Abiomed Field Service team\n800-422-8666",
      "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.",
      "root_cause_description": "Device Design",
      "action": "Abiomed notified consignees via letter on about 08/20/2025. Consignees were instructed to quarantine and cease use of all affected units, contact Abiomed Field Service team to initiate the remediation process, complete and return the business reply form with the assistance of your Abiomed Representative, forward the recall notification to any applicable personnel and notify customers if affected units were further distributed or transferred.   Abiomed also posted a version of the recall notification letter on their website.",
      "product_quantity": "71 units",
      "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.",
      "openfda": {
        "pma_number": [
          "P140003"
        ],
        "registration_number": [
          "2528981",
          "3007904765",
          "1220648"
        ],
        "fei_number": [
          "2528981",
          "3007904765",
          "1220648"
        ],
        "device_name": "Temporary Non-Roller Type Left Heart Support Blood Pump",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}