{
  "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": "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-2218-2023",
      "product_description": "TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                    Part Number    7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES\tD684-00-0545-01  TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES\tD684-00-0546-01  TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES\tD684-00-0607  TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES\tD684-00-0608  PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs\tD884-00-0019-18  PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs\tD884-00-0019-26",
      "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 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES 10607567107656 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES 10607567107663 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES 10607567111711 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES 10607567111728 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs 10607567107684 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs 10607567111810"
    }
  ]
}