{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "7000 Central Ave NE",
      "reason_for_recall": "Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump.  The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.",
      "address_2": "",
      "product_quantity": "261,109 total devices  estimated implanted Worldwide",
      "code_info": "all SynchroMed II pumps",
      "center_classification_date": "20130625",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide",
      "state": "MN",
      "product_description": "Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.)  Sterilized using ethylene oxide.     Product Usage:     The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site.  The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories.      The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer.",
      "report_date": "20130703",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Medtronic Neuromodulation",
      "recall_number": "Z-1570-2013",
      "initial_firm_notification": "Visit",
      "product_type": "Devices",
      "event_id": "65135",
      "termination_date": "20150514",
      "more_code_info": "",
      "recall_initiation_date": "20130603",
      "postal_code": "55432-3568",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}