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    St. Jude Medical Cardiac Rhythm Management Division

    Manufacturer
    🇺🇸 United States

    St. Jude Medical Coordination Center

    Authorized representative
    🇧🇪 Belgium·5 Manufacturers

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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.

    FDA Recall
    Terminated ·St Jude Medical, Cardiac Rhythm Management Division·Product code MXC·April 13, 2018

    ST. JUDE RIATA ICD LEAD

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL·Product code LWS·September 14, 2010

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code MXC·March 31, 2011

    Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

    FDA Recall
    Terminated ·St Jude Medical, Cardiac Rhythm Management Division·Product code NVZ·January 22, 2020

    Merlin PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).

    FDA Recall
    Terminated ·St Jude Medical Cardiac Rhythm Management Division·Product code LWS·November 3, 2015

    Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code LWS·March 10, 2022

    Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code LWS·March 10, 2022

    Merlin PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code OSR·March 10, 2022

    Merlin.net model MN5000 Software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

    FDA Recall
    Terminated ·St Jude Medical Cardiac Rhythm Management Division·Product code NVZ·December 18, 2014

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Recall
    Terminated ·St Jude Medical Cardiac Rhythm Management Division·Product code LWS·August 19, 2014

    Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.

    FDA Recall
    Terminated ·St Jude Medical Cardiac Rhythm Management Division·Product code NVZ·August 18, 2015

    Merlin 2 PCS MER3700 programmer Model MER3400 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code NIK·March 10, 2022

    Merlin 2 PCS MER37000 programmer Model MER3400 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code LWS·March 10, 2022

    Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·April 27, 2022