{ "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": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Sylmar", "address_1": "15900 Valley View Ct", "reason_for_recall": "The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. 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3183771 3179265 3188978 3182292 3187147 3184523 3179435 3189767 3189483 3189810 3188962 3184322 3182523 3188001 3184779 3179181 3183346 3184517 3179267", "center_classification_date": "20180629", "distribution_pattern": "U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,", "state": "CA", "product_description": "St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.", "report_date": "20180711", "classification": "Class II", "openfda": {}, "recalling_firm": "St Jude Medical Inc.", "recall_number": "Z-2334-2018", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "product_type": "Devices", "event_id": "80244", "termination_date": "20210204", "more_code_info": "", "recall_initiation_date": "20180416", "postal_code": "91342-3577", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }