{
  "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": "2026-03-18",
    "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": "92321",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 &",
      "address_2": "24 Cherry Hill Dr",
      "postal_code": "01923-2575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide.",
      "recall_number": "Z-2114-2023",
      "product_description": "Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100",
      "product_quantity": "9252 units",
      "reason_for_recall": "There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.",
      "recall_initiation_date": "20230614",
      "center_classification_date": "20230714",
      "report_date": "20230726",
      "code_info": "UDI-DI: 00813502011531, 00813502012828;",
      "more_code_info": ""
    }
  ]
}