BEUDAMED
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    PULSE GEN MODEL 103

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·February 1, 2013

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA classification
    FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·June 3, 2021

    VALITUDE CRT-P Pacemaker

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·December 7, 2017

    Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code NKE·June 7, 2013

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·June 3, 2021

    CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENEWAL TR model H120 = 359, model H125 = 235; TR2 model H140 = 613, model H145 = 390.

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

    VISIONIST X4 CRT-P Pacemaker

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·December 7, 2017

    VISIONIST CRT-P Pacemaker

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·December 7, 2017

    Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NKE·June 21, 2018

    VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·December 12, 2024

    VALITUDE X4 CRT-P Pacemaker

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·December 7, 2017

    Model Number U225 VISIONIST CRT-P EL

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·August 20, 2025

    Model Number U125, VALITUDE CRT-P EL

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·August 20, 2025

    Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code NKE·November 9, 2015

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·August 20, 2025

    Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NKE·June 21, 2018

    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·June 3, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·June 3, 2021