{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Danvers",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93501",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "24 Cherry Hill Dr",
      "address_2": "",
      "postal_code": "01923-2575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Foreign:  Country  AT AU BE BR CA CA  CH CZ DE DK ES FR FR  HK IN IT MX MY NL NO PA SG TW UK",
      "recall_number": "Z-0646-2024",
      "product_description": "Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body.  Part Number: 0052-3006\t  Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)",
      "product_quantity": "717 single units; 1906 within sets",
      "reason_for_recall": "Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis",
      "recall_initiation_date": "20231107",
      "center_classification_date": "20240105",
      "report_date": "20240117",
      "code_info": "UDI-DI: 00885672009755",
      "more_code_info": ""
    }
  ]
}