{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
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  },
  "results": [
    {
      "cfres_id": "192750",
      "product_res_number": "Z-0956-2022",
      "event_date_initiated": "2022-03-24",
      "event_date_created": "2022-04-19",
      "recall_status": "Open, Classified",
      "res_event_number": "89872",
      "product_code": "OAE",
      "pma_numbers": [
        "P130026"
      ],
      "product_description": "Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.",
      "code_info": "Lot numbers:  8162700, 8164687, 8164730, 8172360, 8173365, 8173840, 8175413, 8177068, 8177349, 8177442, 8179358, 8179499, 8180723, 8180900, 8181043, 8182658, 8183581, 8183595, 8184393, 8184739, 8184817, 8186470, 8186747, 8186860, 8188124, 8188351, 8188844, 8190306, 8190438, 8191524, 8192181, 8192250, 8194325, 8195968, 8196343, 8196367, and 8197913.\n\n\nUDI (01)05415067027641(17)230331(10)xxxxxxx (lot number).",
      "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": "Devices were manufactured with a \"First Use Date\" preprogrammed in the EEPROM which disables the use of the single-use device.",
      "root_cause_description": "Process control",
      "action": "The recalling firm issued letters dated 3/24/2022 on 3/24/22 via hand-delivery.  The letters explained the issue, the impact and associated risks, and the steps to reduce risk.  The steps included not using any of the remaining inventory of the affected lots listed in Appendix A, complete and return the accompanying Acknowledgment Form, and return all remaining unused affected devices to the recalling firm.  The consignee is informed their Abbott representative can assist in returning these devices and obtaining replacements.  The notice is to be forwarded to anyone within their organization who may need to be notified and a copy of the notice should be kept along with the completed Acknowledgment Form for their records.",
      "product_quantity": "2,134 devices",
      "distribution_pattern": "Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.",
      "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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