{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "72501",
      "product_res_number": "Z-0013-2009",
      "event_date_initiated": "2008-06-23",
      "event_date_posted": "2008-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-09-19",
      "res_event_number": "49003",
      "product_code": "MJN",
      "product_description": "Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter\n\nIs indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.",
      "code_info": "Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131",
      "firm_fei_number": "2015691",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92614-5688",
      "additional_info_contact": "949-250-2500",
      "reason_for_recall": "Potential for tubing fracture near the tip of the catheter.",
      "root_cause_description": "Process control",
      "action": "The firm sent Urgent Field Safety Notices dated June 23, 2008 to customers.  The letter gave details on affected products, a description of the problem, and  advise on action to be taken.  Edwards has decided to recall these lots of Fogarty Fortis catheters which were manufactured between 9 June 2007 and 20 June 2008. The expiration date for these lots is between 11 September 2009 and 26 September 2009. The attached sheet lists product by model and lot number which you have ordered during that time frame. Please stop using these lots of catheter products immediately. Edwards requests that you return all Fogarty Fortis catheters from these lots that are still in your inventory. \n\nPlease call Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. \n \nAfter you have verified your inventory, please complete the attached Confirmation Form, even if you no longer have any affected units at your facility. This will allow us to verify the completion of this recall action. \n\nPlease return the Confirmation Form by FAX to: +31.412.47.66.99 , Attention: Mark vanSchijndel \n\nTransmission of this Field Safety Notice: \nThis notice needs to be passed on all those who need to be aware within your organization. \n\nPlease transfer this notice to other organizations on which this action has an impact and where or to any organization where the potentially affected devices have been transferred. \n\nPlease maintain awareness on this notice and resulting action for an appreciate period to ensure effectiveness of the corrective action. \n\nWe sincerely regret the inconvenience caused by this action and greatly appreciate your immediate attention to this matter. If you have specific questions about this notification, please contact Customer Service",
      "product_quantity": "2,975 units",
      "distribution_pattern": "International Distribution --- including countries of Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark, United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South Africa, and Taiwan.",
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