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    ABBOTT AVEIRA DUAL CHAMBER LEADLESS PACEMAKER

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code PNJ·November 15, 2023

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·August 5, 2022

    AVEIR LEADLESS PACEMAKER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code PNJ·July 6, 2021

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·June 29, 2022

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·August 9, 2022

    MICRA¿ AV2

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code PNJ·November 3, 2025

    MICRA¿ VR2

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code PNJ·July 24, 2025

    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PNJ·May 12, 2026

    Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PNJ·February 15, 2025

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PNJ·November 21, 2024

    Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code PNJ·August 6, 2019

    Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code PNJ·August 6, 2019

    Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PNJ·February 5, 2024

    Leadless Pacemaker

    FDA classification
    FDA Class 3 ·Leadless Pacemaker

    MICRA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code PNJ·October 6, 2016

    MICRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code PNJ·October 6, 2016

    MICRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code PNJ·December 9, 2016

    MICRA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code PNJ·December 9, 2016

    MICRA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code PNJ·December 9, 2016

    MICRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code PNJ·December 9, 2016