{
  "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",
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      "cfres_id": "210467",
      "product_res_number": "Z-0302-2025",
      "event_date_initiated": "2024-10-10",
      "event_date_posted": "2024-11-12",
      "recall_status": "Open, Classified",
      "res_event_number": "95514",
      "product_code": "OAE",
      "pma_numbers": [
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      "product_description": "Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160",
      "code_info": "GTIN 00191506016463",
      "firm_fei_number": "2124215",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-5700",
      "additional_info_contact": "Renee Archie\n508-683-4523",
      "reason_for_recall": "Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.",
      "root_cause_description": "Device Design",
      "action": "Boston Scientific disseminated a letter to Physicians/Healthcare Professionals on 10/10/2024 via courier.  The letter notified its consignees of updates to the instructions for use (IFU) for the POLARx and POLARx FIT Cryoablation Catheter related to the risk of atrioesophageal (AE) fistula. The firm requested that the information be shared with clinicians who use the use the Boston Scientific POLARx Cryoablation System, including the POLARx Catheter, the POLARx FIT Catheter and the SMARTFREEZE Console, and to share the communication with any other organization to which these devices may have been transferred.  Users were directed to immediately post the information on or near the product to ensure this information is easily accessible to all users of the device.",
      "product_quantity": "368 units",
      "distribution_pattern": "Worldwide",
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