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    Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

    Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).

    FDA Recall
    Terminated ·Product code NIK·June 17, 2005

    These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·May 15, 2006

    CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·March 23, 2007

    These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF HE (model H239 ) cardiac resynchronization therapy defibrillator (CRT-D).

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·March 23, 2007

    Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy

    FDA Recall
    Terminated ·ela Medical Llc·Product code NIK·June 7, 2010

    Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code NIK·April 3, 2012

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NIK·April 16, 2018

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NIK·October 10, 2016

    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·December 19, 2017

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NIK·August 28, 2017

    These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy 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 NIK·March 23, 2007

    Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·April 7, 2006

    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIK·October 4, 2017

    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·December 19, 2017

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NIK·April 16, 2018

    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.

    FDA Recall
    Terminated ·Abbott·Product code NIK·February 28, 2020

    VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. By using the metallic housing of the pulse generator as an active electrode, combined with the Guidant Endotak two-electrode defibrillation lead, energy is sent via a dual-current pathway from the distal shocking electrode to the proximal electrode and to the pulse generator case. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tacharrhythmias. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 551112-5798 USA.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·March 23, 2007

    CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.

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

    Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF). Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code NIK·May 5, 2010