{
  "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": "98932",
      "product_res_number": "Z-0071-2012",
      "event_date_initiated": "2010-10-25",
      "event_date_posted": "2011-10-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-08-28",
      "res_event_number": "58302",
      "product_code": "LPA",
      "pma_numbers": [
        "P860008"
      ],
      "product_description": "***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com.\n\n ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101.\n\n***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR  SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370  (813) 289-5555. www.cardiocommand.com. 400215-A 100902.",
      "code_info": "Lot Numbers: 1026504, 1023803, 1022901, 1019007, and 1020106.",
      "firm_fei_number": "1927197",
      "recalling_firm": "Cardiocommand Inc.",
      "address_1": "4920 W Cypress St",
      "address_2": "Suite 110",
      "city": "Tampa",
      "state": "FL",
      "postal_code": "33607-3837",
      "additional_info_contact": "Leigh A. Haller\n813-289-5555 Ext. 225",
      "reason_for_recall": "CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall.  The letter identified the affected product and reason for the recall.  Users were asked to discontinue use and return the affected product to the firm.  If all product was already used, then this should be indicated on the form provided.  The firm will send replacement product in quantities equal to the returned product.  The attached form should be completed and returned via fax.  Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370.  Also questions or comments should be directed to CardioCommand Customer Service.",
      "product_quantity": "567 total",
      "distribution_pattern": "Nationwide Distribution -- GA, OR, TX, CO, KY, MT, MA, AL, CA, FL & TN.",
      "openfda": {
        "pma_number": [
          "P860008",
          "P840002"
        ],
        "registration_number": [
          "1927197"
        ],
        "fei_number": [
          "1927197"
        ],
        "device_name": "System, Esophageal Pacing",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}