{
  "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-2217-2023",
      "product_description": "SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta      Product Description                                                                      Part Number    SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0469-01C  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0469-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)\t      D684-00-0470-01C  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)\t      D684-00-0470-07  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY)\tD684-00-0470-09  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES\t                   D684-00-0470-01  SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0470-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY\tD684-00-0469-01U  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES\t                   D684-00-0469-01  SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY\t      D684-00-0469-09  PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs\tD884-00-0019-16",
      "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 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA)       10607567109367 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA)       10607567109732 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA)       10607567109374 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA)       10607567109749 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113135 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES                    10607567106779 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10607567109541 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES                    10607567106755 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY        10607567113128 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs    10607567106724"
    }
  ]
}