{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196194",
      "product_res_number": "Z-0230-2023",
      "event_date_initiated": "2022-10-12",
      "event_date_posted": "2022-11-14",
      "recall_status": "Open, Classified",
      "res_event_number": "90915",
      "product_code": "NQO",
      "pma_numbers": [
        "P140004"
      ],
      "product_description": "Superion Indirect Decompression System (IDS)\n\nModel Numbers and Size:\n101-9808 - 8mm\n01-9812 - 12mm\n101-9814 - 14mm",
      "code_info": "Model (UPN): 101-9808\nUDI-DI (GTIN) Code: 00884662000529\nLot/Batch Numbers:\n26176977\n\nModel (UPN): 101-9812\nUDI-DI (GTIN) Code: 00884662000543\nLot/Batch Numbers:\n26573432\n26375758\n26815560\n26807662\n26654632\n26928168\n26929605\n26489700\n\nModel (UPN): 101-9814\nUDI-DI (GTIN) Code: 00884662000550\nLot/Batch Numbers:\n26366842\n26848047\n26619510\n26323984\n26406210\n26799951",
      "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": "Jessica Sachariason\n415-730-2310",
      "reason_for_recall": "Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface.  As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.",
      "root_cause_description": "Process change control",
      "action": "On 10/12/2022, the firm, Boston Scientific, sent an \"Urgent: Medical Device Recall\" letter via FedEx to customers. The letter described the product, problem and actions to be taken. The Customers are instructed to:\n-Review their facility's device inventory: Segregate and return any unused Superion IDS devices from the affected subset to Boston Scientific. Complete and return account-specific Reply Verification Tracking Form via Email:\tBSCFieldActionCenter@bsci.com \nor Fax to: \tField Action Center at 1-763-415-7708.\n-Patient follow-up: Discuss this advisory with their patient(s) who are implanted with an affected device. Promptly investigate any reported pain and/or discomfort, or any suspected indication of migration of the Superion IDS implant, which may suggest a potential spindle cap weld break. If an affected device remains implanted in their patient, and successful deployment and/or device structural integrity is questioned, consider confirming via imaging. \n-If a spindle cap weld break is confirmed post-implant: Assess the clinical benefits versus risks associated with explanting an affected Superion IDS from their patient. Note that the Superion IDS Inserter tool would be unable to engage a non-intact device for explant. Medical judgement is required for determining the appropriate surgical method for explant in such cases.    \n-Records: For each patient with an affected Superion IDS, append their medical record with a copy of this letter to maintain awareness of this topic for the remaining service life of the device. Should any revision/replacement occur, please inform Boston Scientific with relevant clinical information.\n\nFor additional information or questions - contact the local Boston Scientific representative, or the Firm's Public Contact, Director, Global Corporate Communications at 415-730-2310 or jessica.sachariason@bsci.com.",
      "product_quantity": "175 devices",
      "distribution_pattern": "U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY",
      "openfda": {
        "pma_number": [
          "P140004",
          "P110008",
          "P240043",
          "P040001"
        ],
        "registration_number": [
          "2029275",
          "3003120897",
          "3025435185",
          "3015924373",
          "3006630150",
          "3007766698",
          "2133687",
          "9616693",
          "3018094310",
          "3005426761",
          "3004072627",
          "1450662",
          "3004142400",
          "1423662",
          "2953359",
          "3010173425",
          "1828288",
          "1030489",
          "1047843",
          "3009217531",
          "3010160527",
          "3006783837"
        ],
        "fei_number": [
          "3002807040",
          "3003120897",
          "3025435185",
          "3015924373",
          "3006630150",
          "3007766698",
          "3018094310",
          "3005426761",
          "3004072627",
          "1450662",
          "3000206619",
          "3009322142",
          "3002807036",
          "3004142400",
          "1000306431",
          "3000215273",
          "1828288",
          "1000477302",
          "1047843",
          "3000215205",
          "3009217531",
          "3002618605"
        ],
        "device_name": "Prosthesis, Spinous Process Spacer/Plate",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}