{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "43283",
      "product_res_number": "Z-0469-06",
      "event_date_initiated": "2005-12-12",
      "event_date_posted": "2006-02-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-11-08",
      "res_event_number": "34214",
      "product_code": "DXE",
      "k_numbers": [
        "K042874"
      ],
      "product_description": "AngioJet XMI Rapid Exchange +, 4F, 135 cm.  Contents:  One (1) Thrombectomy Catheter for Peripheral Use.   Sterilized with Ethylene Oxide.  Single Use Only.  Manufactured and Distributed by:  Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN  55433-8003 USA.",
      "code_info": "model number:  105421-002, Lot number 56594",
      "firm_fei_number": "2183460",
      "recalling_firm": "Possis Medical, Inc",
      "address_1": "9055 Evergreen Blvd Nw",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55433-5833",
      "reason_for_recall": "It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.",
      "root_cause_description": "Other",
      "action": "An Advisory Notice was emailed to OUS Distributors 12/12/2005.  The Advisory identifies the product, reason for recall and action Distributor should take.  Distributors are to notify their customer who received the affected lot and return it to the Distributor.  The Distributor is to open the outer box and inspect the catheter inside the sterile tray.  Mislabeled units are to be returned to Possis.",
      "product_quantity": "48",
      "distribution_pattern": "Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.",
      "openfda": {
        "k_number": [
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        "registration_number": [
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        ],
        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}