{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "215493",
      "product_res_number": "Z-2533-2025",
      "event_date_initiated": "2025-08-05",
      "event_date_posted": "2025-09-05",
      "recall_status": "Open, Classified",
      "res_event_number": "97396",
      "product_code": "PTM",
      "product_description": "Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):  \n1.\tH74904526011; \n2.\tH74904526052; \n3.\tM0067101140; \n4.\tM001151050; \n5.\tM001151062; \n6.\tM00566670. \n(Interventional Cardiology, Peripheral Interventions)",
      "code_info": "1. H74904526011, GTIN 8714729177029, Lot Numbers:  34915076, 35065978; \n2. H74904526052, GTIN 8714729127062, Lot Numbers:  34915078, 34915220; \n3. M0067101140, GTIN 8714729755814, Lot Numbers:  34892421; \n4. M001151050, GTIN 8714729183624, Lot Numbers:  34966934; \n5. M001151062, GTIN 8714729137542, Lot Numbers:  34873498; \n6. M00566670, GTIN 8714729755241, Lot Numbers:  35045668.",
      "firm_fei_number": "3002095335",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55311-1565",
      "additional_info_contact": "Clara Johnson\n763-494-1133",
      "reason_for_recall": "The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Boston Scientific issued an Urgent Medical Device Removal notice to it consignees on 8/5/2025 via letter delivered using a traceable means.  The notice explained the issue. potential adverse health consequences associated with use in each device and requested the following instructions be followed:  \n1. Further distribution or use of any remaining devices affected by this removal should cease immediately.  \nDo NOT use affected devices and remove those devices from your facility s inventory.\nSegregate the units in a secure place until they can be returned to Boston Scientific.  \n2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device.  \n3. Forward this notice to any healthcare professional from your organization and to any\nfacilities where affected devices have been transferred, including hospitals or sites within your network.\nIf you are a distributor, this notice must be forwarded to your customers to ensure\nnotification of this device removal is carried out to the end-user level.  \n4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed\ninstructions on page four of the notice  \n5. Return affected devices. The entire Encore 26 Advantage Kit, NephroMax Kit, or\nUroMax Ultra Kit must be returned in order to be reimbursed.  \nFor questions, please contact your local sales representative.",
      "product_quantity": "39739 units",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "device_name": "Syringe, Balloon Inflation, Exempt",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2",
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