{
  "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-2137-2013",
      "product_description": "Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation:     The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.    1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F.    2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN #  M001PCBO4015140F0, Catalogue # PCBO4015140F.",
      "product_quantity": "1,331",
      "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 # 001BPM4015140F0, Catalogue #BPM4015140F.   Lot#'s  15778169,   15735527,  15774378,  15788826,  15812347,  15824636,  15825277,  15836626,  15873338,  15891705,   15931291,  15945240,  16057260.    UPN# M001PCBM4015140F0, Catalogue #PCBM4015140F, Lot #15756145.      UPN # M001PCBO4015140F0, Catalogue #PCBO4015140F,   Lot #'s 15688199,  15992736,  16066536,  16141255.",
      "more_code_info": ""
    }
  ]
}