{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "194347",
      "product_res_number": "Z-1344-2022",
      "event_date_initiated": "2022-06-09",
      "event_date_posted": "2022-07-07",
      "recall_status": "Open, Classified",
      "res_event_number": "90414",
      "product_code": "OAE",
      "pma_numbers": [
        "P130026S036"
      ],
      "product_description": "Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ.  For mapping of the heart chambers during ablation.",
      "code_info": "UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811",
      "firm_fei_number": "3005334138",
      "recalling_firm": "Abbott",
      "address_1": "5050 Nathan Ln N",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55442-3209",
      "additional_info_contact": "Shelley Lange\n651-756-4091",
      "reason_for_recall": "When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: \"invalid catheter,, or \"expired catheter.\"",
      "root_cause_description": "Device Design",
      "action": "The firm notified its consignees by hand delivered Medical Device Recall letter on 06/09/2022.  The letter explained the problem and provided the following instructions:  \n\"Next Steps\nTo help reduce risk, we recommend:\n\"\tDo not use any remaining inventory from the affected lots listed in Appendix A.\n\"\tComplete and return the accompanying Acknowledgement Form to Abbott.\n\"\tReturn all remaining unused affected devices to Abbott. Your Abbott representative can assist you in returning these devices and obtaining replacements.\nPlease forward this notice to anyone within your organization who may need to be notified and maintain a record of this notice along with a copy of the completed Acknowledgement Form for your records.\"",
      "product_quantity": "191 devices",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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