{
  "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-2222-2023",
      "product_description": "SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES\tD684-00-0576-01  SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE \tD684-00-0576-03  SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE \tD684-00-0576-05  SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0576-09  SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0576-01U  PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB  D884-00-0019-23",
      "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 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES 10607567108605 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE  10607567109435 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE  10607567109381 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113173 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109633 PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB  10607567108599"
    }
  ]
}