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    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·January 30, 2017

    Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

    FDA Recall
    Open, Classified ·Medtronic, Inc.·Product code KRG·June 17, 2025

    Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code KRG·July 22, 2010

    The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code KRG·September 29, 2016

    PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code KRG·June 16, 2005

    St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code KRG·October 6, 2006

    Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

    FDA Recall
    Open, Classified ·Medtronic, Inc.·Product code KRG·June 17, 2025

    VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT, model A155. VITALITY DS DR/VR (Models T125, T135), VITALITY 2 DR/VR (Models T165, T175) and VITALITY 2 EL DR/VR (Models T167, T177) Implantable Cardioverter Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code KRG·March 15, 2010

    Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.

    FDA Recall
    Terminated ·Guidant Corporation·Product code KRG·June 17, 2005

    The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code KRG·September 29, 2016

    St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code KRG·October 6, 2006

    Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: VENTAK PRIZM VR model 1860 = 67; DR model 1861 = 108.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code KRG·June 24, 2006

    Programmer, Pacemaker

    FDA classification
    FDA Class 3 ·Programmer, Pacemaker

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code KRG·October 13, 2016

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 6, 2016

    MERLIN PROGRAMMER

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code KRG·November 15, 2016

    ORCHESTRA

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code KRG·November 29, 2016

    MERLIN PROGRAMMER

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code KRG·November 4, 2016

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·December 9, 2016

    MERLIN PROGRAMMER

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code KRG·December 22, 2016