{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Sunnyvale",
      "address_1": "945 Stewart Dr Ste 100",
      "reason_for_recall": "It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter.  This could result in blood stagnation, clots or air emboli.",
      "address_2": "",
      "product_quantity": "60 units",
      "code_info": "All Lots",
      "center_classification_date": "20210329",
      "distribution_pattern": "Product was not distributed in the US.     OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada",
      "state": "CA",
      "product_description": "EPIX Therapeutics  DiamondTemp Unidirectional Large Curve Ablation  Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO,  UDI: 00812499030259",
      "report_date": "20210407",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "EPIX THERAPEUTICS, INC",
      "recall_number": "Z-1318-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "87412",
      "more_code_info": "",
      "recall_initiation_date": "20210222",
      "postal_code": "94085-3940",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}