{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "214843",
      "product_res_number": "Z-2278-2025",
      "event_date_initiated": "2025-06-25",
      "event_date_posted": "2025-08-08",
      "recall_status": "Open, Classified",
      "res_event_number": "97207",
      "product_code": "QZI",
      "pma_numbers": [
        "P230030"
      ],
      "product_description": "FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401",
      "code_info": "UDI-DI: 00191506043148;\nBatch Numbers: 36543581\n36543644\n36543646\n36568553\n36572565\n36572568\n36572571\n36572576\n36578308\n36578314\n36579110\n36598352\n36598809\n36599402\n36600406\n36600543\n36600544\n36600545\n36600578",
      "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": "Clara Johnson\n763-494-1133",
      "reason_for_recall": "The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "An Urgent Medical Device Removal - Immediate Action Required notification letter dated June 2025 was sent to customers.\n\nActions\n1. Do NOT use affected product (Attachment 1), remove affected devices from your facility s inventory, segregate 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 products to ensure this information is readily accessible to all handlers and users of the device.\n3. Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred.\n4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page five.\n5. Return affected product.\n\nEmail: BSCFieldActionCenter@bsci.com\n\nReach out to your local Boston Scientific representative with any questions.",
      "product_quantity": "445 units",
      "distribution_pattern": "US Nationwide.",
      "openfda": {
        "pma_number": [
          "P240006",
          "P240013",
          "P250022",
          "P230030",
          "P230017",
          "P240044"
        ],
        "registration_number": [
          "3012263546",
          "3013403214",
          "3001592626",
          "2182269",
          "1319639",
          "3009380063",
          "2182208",
          "3007603855",
          "3011120183",
          "3012520654",
          "3004105270",
          "3012260771",
          "1721983",
          "3007029079",
          "1000121056",
          "3008328679",
          "3002807314",
          "3012179728",
          "2032112",
          "2124215",
          "2024024",
          "9681260",
          "3004016520",
          "2183744",
          "9680579",
          "2184149",
          "1928237",
          "3005334138",
          "3016245399",
          "3000279201",
          "3004859241",
          "3007648309",
          "1721686",
          "3009504230",
          "3004593495",
          "3002648230",
          "3005012805",
          "9612164",
          "3017060084",
          "9673241",
          "3009243923",
          "3013300026",
          "3008452825",
          "3012693387",
          "3008093809"
        ],
        "fei_number": [
          "3012263546",
          "3013403214",
          "3001592626",
          "2182269",
          "1000138054",
          "3009380063",
          "2182208",
          "3007603855",
          "3011120183",
          "3012520654",
          "3004105270",
          "3012260771",
          "3007029079",
          "1000121056",
          "3008328679",
          "3002807314",
          "3012179728",
          "2124215",
          "1000203464",
          "2024024",
          "3004016520",
          "2183744",
          "1928237",
          "3005334138",
          "3003076831",
          "3016245399",
          "3000279201",
          "3004859241",
          "3007648309",
          "1721686",
          "3002806565",
          "3009504230",
          "3004593495",
          "3002648230",
          "3005012805",
          "1000064530",
          "3017060084",
          "1000139754",
          "3003248396",
          "3002806434",
          "3009243923",
          "3013300026",
          "3008452825",
          "3012693387",
          "3008093809"
        ],
        "device_name": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}