{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177019",
      "product_res_number": "Z-0345-2020",
      "event_date_initiated": "2019-09-04",
      "event_date_created": "2019-11-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-01-21",
      "res_event_number": "84025",
      "product_code": "OZD",
      "pma_numbers": [
        "P140003"
      ],
      "product_description": "lmpella CP with Smart Assist,  Model Number: 0048-0003.  Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI",
      "code_info": "UDI: (01)00813502011371(10)1430951(17)210331(21)192148A;   Serial Number: 192148A",
      "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": "Ralph Barisano\n978-882-8068",
      "reason_for_recall": "This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The affected device was retrieved from the only customer on 9/4/19.  An Urgent Medical Device Recall notification letter dated 9/12/19 was sent to that customer as well.",
      "product_quantity": "1",
      "distribution_pattern": "The product was distributed to GA",
      "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"
      }
    }
  ]
}