{
  "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-2220-2023",
      "product_description": "MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  MEGA 8Fr. 50cc IAB WITH STATLOCK\tD684-00-0296-01  MEGA 8Fr. 50cc IAB WITH STATLOCK & APA\tD684-00-0296-02  MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK)\tD684-00-0296-03  MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0296-09  MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY)\tD684-00-0296-10  MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0296-01U  MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY\tD684-00-0296-02U  MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA)\tD684-00-0498-01  MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA)\tD684-00-0498-07  MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA)\tD684-00-0498-08  PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB   D884-00-0019-17",
      "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 MEGA 8Fr. 50cc IAB WITH STATLOCK 10607567108001 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA 10607567108018 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109411 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113265 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113272 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109619 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109626 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) 10607567107301 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) 10607567109756 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109763 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB  10607567107493"
    }
  ]
}