{
  "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": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "710 Medtronic Pkwy",
      "reason_for_recall": "Medtronic identified an issue with specific models and lots of the PowerCross .018\u001d Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.",
      "address_2": "NE Mailstop LS245",
      "product_quantity": "315",
      "code_info": "UDI/Product         Lot/Serial Product Number     UPN/GTIN Number  00821684046647      A358626                             AB18W030100150  00821684046883      A357386                             AB18W060100150  00821684046722      A357070                             AB18W040100150  00821684046777      A358043                             AB18W050040150  00821684046722      A356360                             AB18W040100150  00821684046777      A357348                             AB18W050040150  00821684046562      A359219                             AB18W025040150",
      "center_classification_date": "20161222",
      "distribution_pattern": "NY, NC, WA",
      "state": "MN",
      "product_description": "ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO.  The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.",
      "report_date": "20161228",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Inc",
      "recall_number": "Z-0892-2017",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "75780",
      "termination_date": "20170802",
      "recall_initiation_date": "20161110",
      "postal_code": "55432-5603",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}