{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72409",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "2 Scimed Pl",
      "address_2": "N/A",
      "postal_code": "55311-1565",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa.",
      "recall_number": "Z-0211-2016",
      "product_description": "RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy.  REF H802223301 (5-pack outer package), REF H802223300 (single unit).        The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions.  This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended.      The guidewires are intended for use with the Rotablator Rotational Atherectomy System.",
      "product_quantity": "955 single units (191 5-packs)",
      "reason_for_recall": "Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.",
      "recall_initiation_date": "20151009",
      "center_classification_date": "20151112",
      "termination_date": "20171013",
      "report_date": "20151118",
      "code_info": "Lots:  18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 18362094, 18378161, 18379210, 18384443"
    }
  ]
}