{
  "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": "2026-08-20",
    "results": {
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      "limit": 1,
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  "results": [
    {
      "cfres_id": "131893",
      "product_res_number": "Z-0877-2015",
      "event_date_initiated": "2014-10-06",
      "event_date_posted": "2014-12-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-24",
      "res_event_number": "69879",
      "product_code": "MAV",
      "k_numbers": [
        "K110604"
      ],
      "product_description": "Synthes Inflation System (03.804.4135) \n\nProduct Usage:\nInflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter",
      "code_info": "Batch numbers: 4041354/4062650/4072586",
      "firm_fei_number": "3006942524",
      "recalling_firm": "PEROUSE MEDICAL",
      "address_1": "ROUTE DU MANOIR",
      "city": "Ivry Le Temple",
      "country": "France",
      "reason_for_recall": "Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure",
      "root_cause_description": "Device Design",
      "action": "Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and  October 07,  2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements.  US distributors have been requested to provide the required information to their customers.   In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.",
      "product_quantity": "2184 units",
      "distribution_pattern": "US Nationwide Distribution in the states of AZ and CO.",
      "openfda": {
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        "device_name": "Syringe, Balloon Inflation",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}