{
  "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-0089-2021",
      "product_description": "Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen  Product number: 007161  GTIN: 00613994760272    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": "505 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 :   GFCR2342  GFCR2583  GFCX2785  GFCY3003  GFDN0248  GFDQ2501  GFDR2902  GFDS2211  GFDT2171  GFDT2201  GFDU2169  GFDV2178  GFDW2400  GFDX2710  GFDY1133  GFDY1134"
    }
  ]
}