{
  "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": [
    {
      "status": "Terminated",
      "city": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65919",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "address_2": "N/A",
      "postal_code": "55311-1565",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI.  Internationally to Algeria, Finland,  Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.",
      "recall_number": "Z-2138-2013",
      "product_description": "Boston Scientific, FlextomeTM Cutting BalloonTM,  Sterilized using irradiation:     1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015     2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015    The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: \" Discrete (< 15 mm in length), or tubular (10 to 20 mm in length) \" Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm \" Readily accessible to the device \" Light to moderate tortuosity of proximal vessel segment \" Nonangulated lesion segment (< 45¿) \" Smooth angiographic contour \" Absence of angiographically visible thrombus and/or calcification.",
      "product_quantity": "340",
      "reason_for_recall": "Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices.  Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic",
      "recall_initiation_date": "20130731",
      "center_classification_date": "20130903",
      "termination_date": "20150127",
      "report_date": "20130911",
      "code_info": "UPN #                             Catalogue #     Lot #  H749CBM3400150 CBM340015 15777251,  15898645, 16125358.    H749RB4400150 RB440015 15780571.      H749CBO3400150       CBO340015 15854224.",
      "more_code_info": ""
    }
  ]
}