{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217590",
      "product_res_number": "Z-1030-2026",
      "event_date_initiated": "2025-12-04",
      "event_date_posted": "2026-01-08",
      "recall_status": "Open, Classified",
      "res_event_number": "98086",
      "product_code": "OZD",
      "pma_numbers": [
        "P140003"
      ],
      "product_description": "Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.",
      "code_info": "Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.\n*** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;",
      "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": "Field Actions Team\n978-646-1400",
      "reason_for_recall": "Device packaged in incorrect outer box carton.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The consignee was sent a RECALL notice dated 12/4/25. The consignee is instructed to identify the two affected pumps in their inventory, quarantine them, and return the units to Abiomed, Danvers. The consignee is to complete and return the provided business reply form to their local Abiomed representative.",
      "product_quantity": "6 units",
      "distribution_pattern": "International distribution to the country of Australia and Taiwan.",
      "openfda": {
        "pma_number": [
          "P140003"
        ],
        "registration_number": [
          "3007904765",
          "2528981",
          "1220648"
        ],
        "fei_number": [
          "3007904765",
          "2528981",
          "1220648"
        ],
        "device_name": "Temporary Non-Roller Type Left Heart Support Blood Pump",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}