{
  "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": "Ongoing",
      "city": "Merrimack",
      "state": "NH",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89852",
      "recalling_firm": "Atrium Medical Corporation",
      "address_1": "40 Continental Blvd",
      "address_2": "N/A",
      "postal_code": "03054-4332",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Foreign:  Australia  Austria  Bahrain  Belgium  Bosnia-Herzegovina  Brazil  Bulgaria  Canada  Chile  Colombia  Costa Rica  Cyprus  Czech Republic  Denmark  Ecuador  Egypt  El Salvador  Estonia  Finland  France  Germany  Great Britain  Greece  Hong Kong  Hungary  Iceland  Ireland, Republic of  Israel  Italy  Japan  Jordan  Kuwait  Latvia  Lebanon  Lithuania  Macedonia  Malaysia  Malta  Mexico  Netherlands  New Zealand  Norway  Panama  Paraguay  Peru  Philippines  Poland  Portugal  Qatar  Reunion  Russia  San Marino  Saudi Arabia  Singapore  Slovak Republic  Slovenia  South African Republic  South Korea  Spain  Sweden  Switzerland  Taiwan,  Thailand  Trinidad and Tobago  Turkey  United Arab Emirates  Uruguay  Vietnam",
      "recall_number": "Z-1077-2022",
      "product_description": "iCast Covered Stent System    Product Code/Part Number:  85400  85401  85402  85403  85404  85405  85406  85407  85408  85409  85410  85411  85412  85413  85414  85415  85416  85417  85418  85419  85420  85424  85440  85441  85442  85443  85444  85445  85450  85451  85452  85453  85454  85455      Product Code/UDI /Description:  85400 00650862854008\tiCAST COVERED STENT,5MMX38MMX80CM  85401 00650862854015\tiCAST COVERED STENT,5MMX59MMX80CM  85402 00650862854022\tiCAST COVERED STENT,6MMX38MMX80CM  85403 00650862854039\tiCAST COVERED STENT,6MMX59MMX80CM  85404 00650862854046\tiCAST COVERED STENT,7MMX38MMX80CM  85405 00650862854053\tiCAST COVERED STENT,7MMX59MMX80CM  85406 00650862854060\tiCAST COVERED STENT,8MMX38MMX80CM  85407 00650862854077\tiCAST COVERED STENT,8MMX59MMX80CM  85408 00650862854084\tiCAST COVERED STENT,9MMX38MMX80CM  85409\t00650862854091\tiCAST COVERED STENT,9MMX59MMX80CM  85410\t00650862854107\tiCAST COVERED STENT,5MMX38MMX120CM  85411\t00650862854114\tiCAST COVERED STENT,5MMX59MMX120CM  85412\tiCAST COVERED STENT,6MMX38MMX120CM  85413 00650862854138\tiCAST COVERED STENT,6MMX59MMX120CM  85414 00650862854145\tiCAST COVERED STENT,7MMX38MMX120CM  85415 00650862854152\tiCAST COVERED STENT,7MMX59MMX120CM  85416 00650862854169\tiCAST COVERED STENT,8MMX38MMX120CM  85417 00650862854176\tiCAST COVERED STENT,8MMX59MMX120CM  85418 00650862854183\tiCAST COVERED STENT,9MMX38MMX120CM  85419 00650862854190\tiCAST COVERED STENT,9MMX59MMX120CM  85420 00650862854206\tiCAST COVERED STENT,10MMX38MMX80CM  85424 00650862854244\tiCAST COVERED STENT,10MMX38MMX120CM  85440 00650862854404\tiCAST COVERED STENT,5MMX16MMX80CM  85441 00650862854411\tiCAST COVERED STENT,5MMX22MMX80CM  85442 00650862854428\tiCAST COVERED STENT 6MMX16MMX80CM  85443 00650862854435\tiCAST COVERED STENT,6MMX22MMX80CM  85444 00650862854442\tiCAST COVERED STENT,7MMX16MMX80CM  85445 00650862854459\tiCAST COVERED STENT,7MMX22MMX80CM  85450 00650862854503\tiCAST COVERED STENT,5MMX16MMX120CM  85451 00650862854510\tiCAST COVERED STENT,5MMX22MMX120CM  85452 00650862854527\tiCAST COVERED STENT,6MMX16MMX120CM  85453 00650862854534\tiCAST COVERED STENT,6MMX22MMX120CM  85454 00650862854541\tiCAST COVERED STENT,7MMX16MMX120CM  85455 00650862854558\tiCAST COVERED STENT,7MMX22MMX120CM",
      "product_quantity": "68812 units",
      "reason_for_recall": "Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction.  ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.",
      "recall_initiation_date": "20220303",
      "center_classification_date": "20220518",
      "report_date": "20220525",
      "code_info": "All lots",
      "more_code_info": ""
    }
  ]
}