{
  "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-0088-2021",
      "product_description": "Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen  Product number: 007160  GTIN: 00613994760265    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": "711 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 :   GFCT1699  GFCT2030  GFCW2430  GFCX2784  GFCY2476  GFCY3001  GFDN0247  GFDN3546  GFDR2901  GFDT2170  GFDT2200  GFDU2168  GFDV2177  GFDW2388  GFDW2389  GFDW2399  GFDX2709  GFDY1132  GFDZ1690  GFDZ1691  GFEN2173"
    }
  ]
}