{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "37178",
      "product_res_number": "Z-0707-05",
      "event_date_initiated": "2005-01-27",
      "event_date_posted": "2005-04-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-03-29",
      "res_event_number": "31116",
      "product_code": "MAF",
      "pma_numbers": [
        "P810046S216"
      ],
      "product_description": "Voyager RX Coronary Dilatation Catheter",
      "code_info": "Catalog numbers apply in this recall situation as follows: Balloon Diameter (mm)\tBalloon Length (mm) \t8\t12\t15\t20\t25\t30 1.50\tN/A\t1011391-12\t1011391-15\tN/A\tN/A\tN/A 2.00\t1011392-08\t1011392-12\t1011392-15\t1011392-20\t1011392-25\t1011392-30 2.25\t1011393-08\t1011393-12\t1011393-15\t1011393-20\t1011393-25\t1011393-30 2.50\t1011394-08\t1011394-12\t1011394-15\t1011394-20\t1011394-25\t1011394-30 2.75\t1011395-08\t1011395-12\t1011395-15\t1011395-20\t1011395-25\t1011395-30 3.00\t1011396-08\t1011396-12\t1011396-15\t1011396-20\t1011396-25\t1011396-30 3.25\t1011397-08\t1011397-12\t1011397-15\t1011397-20\t1011397-25\t1011397-30 3.50\t1011398-08\t1011398-12\t1011398-15\t1011398-20\t1011398-25\t1011398-30  Column at the left represents the diameter.  The last tow digits after the hyphen indicate the length.    Lot Numbers  The full list of lot numbers being recalled exceeds 1000.  The scope of the recall involves all lots of the sizes given above that have lot numbers in the range:  40101XX through 41231XX, inclusive where XX can be any digits.   For reference lot numbers are date coded: YMMDDLS  Where Y=last digit of year manufactured, MM=month manufactured, DD=day manufactured, L=location manufactured, (5= Temecula CA, 3= Clonmel Ireland, S=sequence (1= first lot of day, 2= second lot of day).  TO IDENTIFY A UNIQUE PRODUCT ONE NEEDS BOTH THE PART NUMBER AND LOT NUMBER (MULTIPLE PART NUMBERS AER ASSIGNED THE SAME LOT NUMBER PER THE CONVENTION ABOVE.",
      "firm_fei_number": "2024168",
      "recalling_firm": "Guidant Corporation Advanced CardiovascularSystem",
      "address_1": "26531 Ynez Rd",
      "city": "Temecula",
      "state": "CA",
      "postal_code": "92591-4630",
      "additional_info_contact": "James C. McMahon. PhD\n951-914-2400",
      "reason_for_recall": "Leak at guide wire exit notch could introduce air into the artery.",
      "root_cause_description": "Other",
      "action": "Firm notified affiliates in foreign countries and distributors of the recall on 01/27/2005. Recall is on-going.",
      "product_quantity": "180,000 units",
      "distribution_pattern": "Worldwide.  Direct to customers in: Austria, Belgium & Luxumburg, Canada, Czech Republic, Denmark, France, Germany, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, The UK.\n\nTo Distributors in: Finland, Iceland, Ireland, Lithuania, Barhain, Bulgaria, Cypres, Greece, Hungary, Israel, Jordan, Kuwait, Lebanon, Morocco, Poland, Russia, Saudi Arabia, South Africa, Syria, Tunisia, Turkey, UAE.\n\nAlso countries in South and Central America although specifics are not known as above. \n\nFirm communicated with Competent Authorities in the 30 countries listed above.",
      "openfda": {
        "pma_number": [
          "P910030",
          "P970020",
          "P960010",
          "P020040",
          "P040016",
          "P030037",
          "P000022",
          "P970061",
          "P000011",
          "P130030",
          "P940019",
          "P980001",
          "P970035",
          "P030009",
          "P020047",
          "P900043",
          "P980009",
          "P950020",
          "P160003",
          "P150039",
          "P110004",
          "P160014",
          "P020009",
          "P810046"
        ],
        "registration_number": [
          "3005111382",
          "2011171",
          "1000121056",
          "1225687",
          "3014656749",
          "3005718570",
          "3002807315",
          "2029275",
          "2124215",
          "2024168",
          "3004091615",
          "2939561",
          "2024024",
          "3010273872",
          "3002807314",
          "9681260",
          "3016248656",
          "2134265",
          "8043892",
          "3005941719",
          "3011574793"
        ],
        "fei_number": [
          "3005111382",
          "2011171",
          "1000121056",
          "3014656749",
          "3005718570",
          "3002807315",
          "3002808050",
          "3001451463",
          "1000306431",
          "2124215",
          "3002095335",
          "3002806565",
          "2024168",
          "3004091615",
          "2024024",
          "3010273872",
          "3002807314",
          "3004635528",
          "3016248656",
          "3002807111",
          "3011574793"
        ],
        "device_name": "Stent, Coronary",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}