{
  "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 EL pumps",
      "center_classification_date": "20130625",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide",
      "state": "MN",
      "product_description": "Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 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 drug is stored in the pump reservoir.  Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site.      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-1571-2013",
      "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"
    }
  ]
}