{
  "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": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92527",
      "recalling_firm": "Datascope Corp.",
      "address_1": "15 Law Dr Unit 1",
      "address_2": "N/A",
      "postal_code": "07004-3206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Domestic distribution nationwide. International distribution worldwide.",
      "recall_number": "Z-2224-2023",
      "product_description": "REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.\tD684-00-0403-05  REINFORCED INTRODUCER SET FOR SENSATION 7Fr.\tD684-00-0403-06  REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.\tD684-00-0403-10",
      "product_quantity": "321,609 total kits",
      "reason_for_recall": "During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.",
      "recall_initiation_date": "20230623",
      "center_classification_date": "20230721",
      "report_date": "20230802",
      "code_info": "Product Description                                                    UDI REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.  10607567106656 REINFORCED INTRODUCER SET FOR SENSATION 7Fr.   10607567106694 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.   10607567107943"
    }
  ]
}