{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "214651",
      "product_res_number": "Z-2558-2025",
      "event_date_initiated": "2025-07-08",
      "event_date_posted": "2025-09-12",
      "recall_status": "Open, Classified",
      "res_event_number": "97144",
      "product_code": "NHL",
      "pma_numbers": [
        "P150031"
      ],
      "product_description": "Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09",
      "code_info": "UDI-DI: 08714729985044, 08714729985051.\n\nDocument Number/Revision:\n92328632-09, Rev A",
      "firm_fei_number": "3006630150",
      "recalling_firm": "Boston Scientific Neuromodulation Corporation",
      "address_1": "25155 Rye Canyon Loop",
      "city": "Valencia",
      "state": "CA",
      "postal_code": "91355-5004",
      "additional_info_contact": "Renee Archie\n508-683-4523",
      "reason_for_recall": "Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of\ntherapy, return of symptoms and/or Bluetooth connectivity challenges.",
      "root_cause_description": "Labeling design",
      "action": "On 7/8/2025, correction notices were mailed in the U.S. and mailed, emailed, or hand delivered outside the U.S.\n\nHealthcare Professionals were asked to do the following:\n1) Review the Surgical Implant Manual updates.\n2) If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them.\n3) A patient letter is enclosed with this communication, which can be shared with your patient and/or included within the patient's medical record.\n4) Monitor per relevant IFU recommendations for any clinical observations of high monopolar impedances, undesired sensation, sudden loss of therapy, return of pre-implant symptoms and/or Bluetooth connectivity challenges, as these may be signals of potential feedthrough wire break(s) (component damage).\n5) If you are a distributor, this notification must be forwarded to your customers to ensure this notification is carried out to the end-user level.\n6) To provide awareness of this information, share this letter with any other clinicians in your hospital who use the system.\n7) Maintain a copy of this letter in your facility's records.\n8) Complete and return the acknowledgement form via email to BSCFieldActionCenter@bsci.com\n\nreport all device-related incidents or quality concerns experienced with the use of these devices to the firm at BSN.ComplaintCallCenter@bsci.com",
      "product_quantity": "25,260",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA, CT, NV, UT, IN, ID, IL, ME, SC, DC, OK, KY, AK, HI, RI, AR, KS, NM and the countries of Argentina, Brazil, Chile, Ecuador, Colombia , Mexico, Canada, Japan, Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkiye, UAE, Ukraine, United Kingdom, Hong Kong, China, Singapore, Korea, Taiwan , India, Thailand.",
      "openfda": {
        "pma_number": [
          "P960009",
          "P150031"
        ],
        "registration_number": [
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        "fei_number": [
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          "3010086866",
          "3006705815",
          "3004369318"
        ],
        "device_name": "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}