{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Danvers",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86381",
      "recalling_firm": "Medtronic Vascular",
      "address_1": "35-37A Cherry Hill Drive",
      "address_2": "N/A",
      "postal_code": "01923-2565",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Worldwide Distribution: USA (nationwide) states of: MA, PA, TN, IN, MI, WA, CA, CO, AZ, NC; and OUS countries of: Algeria, Armenia, Australia, Austria, Barbados, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Macedonia, Malaysia, Martinique, Moldova, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Tunisia, United Arab Emirates, and United Kingdom.",
      "recall_number": "Z-0087-2021",
      "product_description": "Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen  Product number: 008764  GTIN: 00613994760289    The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.",
      "product_quantity": "2356 units",
      "reason_for_recall": "Subsequent failure of catheters in the field and failed quality testing",
      "recall_initiation_date": "20200825",
      "center_classification_date": "20201016",
      "termination_date": "20240404",
      "report_date": "20201028",
      "code_info": "Lot Numbers :   GFCP2154  GFCR2591  GFCR2592  GFCS2156  GFCU2199  GFCV2587  GFCW1652  GFCW2431  GFCX2712  GFCY2997  GFDN0246  GFDN3553  GFDN3554  GFDN3555  GFDP2922  GFDQ2500  GFDR2919  GFDS2209  GFDS2210  GFDT2188  GFDT2189  GFDT2204  GFDT2205  GFDU2170  GFDU2171  GFDV2179  GFDV2180  GFDV2181  GFDW2390  GFDW2391  GFDW2392  GFDX2711  GFDX2712  GFDY1135  GFDY1136  GFDZ1692  GFDZ1693  GFEP1181  GFEP1182  GFEP1183  GFEP1184  GFER2080  GFER2081"
    }
  ]
}