{
  "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-1076-2022",
      "product_description": "Atrium Advanta V12 Covered Stent System (OUS only).    Product Code/Part Number:  85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379.    Product Code/UDI /Description:  85320\t650862853209\tAdvanta V12 Covered Stent, 5mm x 38mm x 80cm;  85321\t650862853216\tAdvanta V12 Covered Stent, 5mm x 59mm x 80cm;  85322\t650862853223\tAdvanta V12 Covered Stent, 6mm x 38mm x 80cm;  85323\t650862853230\tAdvanta V12 Covered Stent, 6mm x 59mm x 80cm  85324\t650862853247\tAdvanta V12 Covered Stent, 7mm x 38mm x 80cm;  85325\t650862853254\tAdvanta V12 Covered Stent, 7mm x 59mm x 80cm;  85326\t650862853261\tAdvanta V12 Covered Stent, 8mm x 38mm x 80cm;  85327\t650862853278\tAdvanta V12 Covered Stent, 8mm x 59mm x 80cm;  85328\t650862853285\tAdvanta V12 Covered Stent, 9mm x 38mm x 80cm;  85329\t650862853292\tAdvanta V12 Covered Stent, 9mm x 59mm x 80cm;  85330\t650862853308\tAdvanta V12 Covered Stent, 5mm x 38mm x120cm;  85331\t650862853315\tAdvanta V12 Covered Stent, 5mm x 59mm x120cm;  85332\t650862853322\tAdvanta V12 Covered Stent, 6mm x 38mm x120cm;  85333\t650862853339\tAdvanta V12 Covered Stent, 6mm x 59mm x120cm;  85334\t650862853346\tAdvanta V12 Covered Stent, 7mm x 38mm x120cm;  85335\t650862853353\tAdvanta V12 Covered Stent, 7mm x 59mm x120cm;  85336\t650862853360\tAdvanta V12 Covered Stent, 8mm x 38mm x120cm;  85337\t650862853377\tAdvanta V12 Covered Stent, 8mm x 59mm x120cm;  85338\t650862853384\tAdvanta V12 Covered Stent, 9mm x 38mm x120cm;  85339\t650862853391\tAdvanta V12 Covered Stent, 9mm x 59mm x120cm;  85340\t650862853407\tAdvanta V12 Covered Stent, 5mm x 16mm x 80cm;  85341\t650862853414\tAdvanta V12 Covered Stent, 5mm x 22mm x 80cm;  85342\t650862853421\tAdvanta V12 Covered Stent, 6mm x 16mm x 80cm;  85343\t650862853438\tAdvanta V12 Covered Stent, 6mm x 22mm x 80cm;  85344\t650862853445\tAdvanta V12 Covered Stent, 7mm x 16mm x 80cm;  85345\t650862853452\tAdvanta V12 Covered Stent, 7mm x 22mm x 80cm;  85350\t650862853506\tAdvanta V12 Covered Stent, 5mm x 16mm x 120cm;  85351\t650862853513\tAdvanta V12 Covered Stent, 5mm x 22mm x 120cm;  85352\t650862853520\tAdvanta V12 Covered Stent, 6mm x 16mm x 120cm;  85353\t650862853537\tAdvanta V12 Covered Stent, 6mm x 22mm x 120cm;  85354\t650862853544\tAdvanta V12 Covered Stent, 7mm x 16mm x 120cm;  85355\t650862853551\tAdvanta V12 Covered Stent, 7mm x 22mm x 120cm;  85360\t650862853605\tAdvanta V12 Covered Stent, 10mm x 38mm x 80cm;  85361\t650862853612\tAdvanta V12 Covered Stent, 10mm x 59mm x 80cm;  85364\t650862853643\tAdvanta V12 Covered Stent, 10mm x 38mm x 120cm;  85365\t650862853650\tAdvanta V12 Covered Stent, 10mm x 59mm x 120cm;  85370\t650862853704\tAdvanta V12 Large Diameter, 12mm x 29mm x 80cm;  85371\t650862853711\tAdvanta V12 Large Diameter, 12mm x 41mm x 80cm;  85372\t650862853728\tAdvanta V12 Large Diameter, 12mm x 61mm x 80cm;  85379\t650862853797\tAdvanta V12 Large Diameter, 12mm x 29mm x 120cm;  85388\t650862853889\tAdvanta V12 Covered Stent, 5mm x 32mm x 80cm;  ;85390\t650862853902\tAdvanta V12 Covered Stent, 7mm x 32mm x 80cm;  85391\t650862853919\tAdvanta V12 Covered Stent, 8mm x 32mm x 80cm;  85392\t650862853926\tAdvanta V12 Covered Stent, 9mm x 32mm x 80cm;  85394\t650862853940\tAdvanta V12 Covered Stent, 5mm x 32mm x 120cm;  85395\t650862853957\tAdvanta V12 Covered Stent, 6mm  x 32mm x 120cm.  85396\t650862853964\tAdvanta V12 Covered Stent, 7mm x 32mm x 120cm  85397\t650862853971\tAdvanta V12 Covered Stent, 8mm x 32mm x 120cm  85398\t650862853988\tAdvanta V12 Covered Stent, 9mm x 32mm x 120cm",
      "product_quantity": "105,968  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": ""
    }
  ]
}