{
  "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": 3
    }
  },
  "results": [
    {
      "cfres_id": "215218",
      "product_res_number": "Z-2325-2025",
      "event_date_initiated": "2025-07-24",
      "event_date_posted": "2025-08-20",
      "recall_status": "Open, Classified",
      "res_event_number": "97318",
      "product_code": "LWS",
      "pma_numbers": [
        "P910073"
      ],
      "product_description": "ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187",
      "code_info": "Model 0161\nUDI-DI/GTIN 00802526372766;\n\nModel 0164\nUDI-DI/GTIN N/A;\n\nModel 0165\nUDI-DI/GTIN 00802526377259;\n\nModel 0167\nUDI-DI/GTIN N/A 00802526373251;\n\nModel 0170\nUDI-DI/GTIN\n00802526373282\n00802526373299;\n\nModel 0171\nUDI-DI/GTIN \n00802526373374\n00802526373381;\n\nModel 0172\nUDI-DI/GTIN\n00802526373466;\n\nModel 0173\nUDI-DI/GTIN\n00802526373558\n00802526373565;\n\nModel 0174\nUDI-DI/GTIN \n00802526373640;\n\nModel 0175\nUDI-DI/GTIN\n00802526373732\n00802526373749;\n\nModel 0176\nUDI-DI/GTIN \n00802526376726\n00802526376733;\n\nModel 0177\nUDI-DI/GTIN\n00802526376818\n00802526376825;\n\nModel 0180\nUDI-DI/GTIN\n00802526411977\n00802526422027\n00802526433597\n00802526531149\n00802526540943\n00802526540950\n00802526591518;\n\nModel 0181\nUDI-DI/GTIN\n00802526411984\n00802526422034\n00802526433689\n00802526433726\n00802526433757\n00802526491009\n00802526502903\n00802526531156;\n\nModel 0182\nUDI-DI/GTIN\n00802526422041\n00802526531163;\n\nModel 0183\nUDI-DI/GTIN\n00802526422058\n00802526531170;\n\nModel 0184\nUDI-DI/GTIN\n00802526412011\n00802526422065\n00802526433986\n00802526433993\n00802526491313\n00802526531187\n00802526541261\n00802526583438;\n\nModel 0185\nUDI-DI/GTIN\n00802526412028\n00802526413438\n00802526422072\n00802526434082\n00802526434099\n00802526434105\n00802526434150\n00802526434174\n00802526470622\n00802526491405\n00802526491412\n00802526491429\n00802526503306\n00802526531194\n00802526541346\n00802526591563\n00802526612541;\n\nModel 0186\nUDI-DI/GTIN\n00802526412035\n00802526422089\n00802526434198\n00802526531200;\n\nModel 0187\nUDI-DI/GTIN\n00802526412042\n00802526422096\n00802526531217",
      "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": "United States Technical Services\n800-227-3422",
      "reason_for_recall": "Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.",
      "root_cause_description": "Component design/selection",
      "action": "On July 24, 2025, firm notified physicians via Important Medical Device Information letters. The letter provides information on the management of gradually rising daily subthreshold, low-voltage shock impedance (LVSI) pattern associated with calcification of expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE defibrillation leads manufactured by Boston Scientific Corporation between 2002 to 2021. Letter includes recommendations for routine follow-ups of affected leads, and considerations to take if lead replacement is planned. The firm is not recommending any changes to the scheduled follow-up interval for patients with ePTFE lead models.",
      "product_quantity": "247,702 US; 344,670 OUS",
      "distribution_pattern": "Worldwide Distribution. US nationwide. International distribution worldwide.",
      "openfda": {
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P980023",
          "P880006",
          "P940008",
          "P910077",
          "P010031",
          "P880086",
          "P900061",
          "P950022",
          "P970013",
          "P110042",
          "P910073",
          "P830060",
          "P930035",
          "P030054",
          "P980049",
          "P220012",
          "P920015",
          "P030035",
          "P970024",
          "P960040",
          "P980050",
          "P890061",
          "P940024",
          "P980016",
          "P010012",
          "P910023",
          "P050023"
        ],
        "registration_number": [
          "3015544746",
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        "fei_number": [
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}