{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "185983",
      "product_res_number": "Z-1317-2021",
      "event_date_initiated": "2021-02-22",
      "event_date_created": "2021-03-29",
      "recall_status": "Open, Classified",
      "res_event_number": "87412",
      "product_code": "OAE",
      "pma_numbers": [
        "P200028"
      ],
      "product_description": "EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation  Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198",
      "code_info": "All Lots",
      "firm_fei_number": "3015180993",
      "recalling_firm": "EPIX THERAPEUTICS, INC",
      "address_1": "945 Stewart Dr Ste 100 945 Stewart Dr",
      "address_2": "Ste 100",
      "city": "Sunnyvale",
      "state": "CA",
      "postal_code": "94085-3940",
      "additional_info_contact": "Kristy Simmons\n408-470-4528",
      "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.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On February 22, 2021, Medtronic issued a \"Urgent Medical Device Correction\" notification via regionally approved methods to consignees who have received affected product. In addition to informing consignees about the recall the firm asked consignees to take the following actions: \n\n\n1. Review the corrected language applicable to IFU and label as provided in the Appendix below. Until the IFU is updated with the corrected information, the information provided in the Appendix should be used in combination with the existing labeling provided with the DiamondTemp\" Catheters.\n\n2. Please share this information with healthcare professionals in your facility that use DiamondTemp\" Catheters. Also share this information with any other organization where these devices may have been transferred.\n\n3. Please maintain a copy of this notice in your records. We are committed to patient safety and welcome any questions you may have regarding this communication. Please contact your Medtronic representative with questions.",
      "product_quantity": "100 units",
      "distribution_pattern": "Product was not distributed in the US. \n\nOUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada",
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        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
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}