{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "95085",
      "product_res_number": "Z-0339-2011",
      "event_date_initiated": "2010-09-10",
      "event_date_posted": "2010-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-11-16",
      "res_event_number": "56973",
      "product_code": "NIM",
      "pma_numbers": [
        "P040012"
      ],
      "product_description": "RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061\nThe RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.",
      "code_info": "Lot Number: 0070961",
      "firm_fei_number": "2024168",
      "recalling_firm": "Abbott Vascular",
      "address_1": "26531 Ynez Rd",
      "city": "Temecula",
      "state": "CA",
      "postal_code": "92591-4630",
      "additional_info_contact": "951-914-2400",
      "reason_for_recall": "The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.",
      "root_cause_description": "Pending",
      "action": "Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees.  The letter identified the product, the problem, and the action to be taken.  The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any\nunused devices to Abbott Vascular.  Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter.\n\nThe consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular.\nFor questions regarding this recall call (951) 914-3324.",
      "product_quantity": "42 units total for all products",
      "distribution_pattern": "Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI",
      "openfda": {
        "pma_number": [
          "P040038",
          "P070012",
          "P180010",
          "P050019",
          "P040012",
          "P060001",
          "P210030",
          "P240029",
          "P240009",
          "P140026",
          "P030047",
          "P050025"
        ],
        "registration_number": [
          "3013556777",
          "3002807314",
          "3015192261",
          "2011171",
          "3010432890",
          "2124215",
          "3004091615",
          "1643817",
          "3011471056",
          "3010079067",
          "2024024",
          "2939561",
          "2024168",
          "9681260",
          "3010173425",
          "1016427",
          "3009756327",
          "3003956144",
          "2183744",
          "3031658894",
          "3022627847",
          "3012865735",
          "9616099",
          "1424778",
          "2183870"
        ],
        "fei_number": [
          "3003528016",
          "3013556777",
          "3004635528",
          "3002807314",
          "3015192261",
          "2011171",
          "3010432890",
          "2124215",
          "3004091615",
          "1643817",
          "3002807036",
          "3011471056",
          "3010079067",
          "2024024",
          "2024168",
          "3002807038",
          "3003473227",
          "1016427",
          "3003956144",
          "2183744",
          "3031658894",
          "3002806565",
          "3022627847",
          "3012865735",
          "2183870"
        ],
        "device_name": "Stent, Carotid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}