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    AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA 1800

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CJY·October 19, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    ENO

    FDA Adverse Event
    Malfunction ·MICROPORT CRM S.R.L.·Product code LWP·June 28, 2023

    ADVIA 1800 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·March 8, 2018

    ACCOLADE MRI EL DR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·March 27, 2025

    ADVIA 1800 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·March 1, 2018

    ADVIA 1800 ANALYZER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·February 23, 2018

    ADVIA 1800

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 24, 2021

    ADVIA 1800 ANALYZER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·December 18, 2024

    ADVIA CHEMISTRY XPT

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 5, 2019

    ADVIA 1800

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 16, 2021

    ADVIA 1800

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 22, 2021

    ADVIA 2400

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 27, 2016

    MEDTRONIC LEAD

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DXY·January 26, 2026

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA classification
    FDA Class 3 ·Implantable Pulse Generator, Pacemaker (Non-Crt)

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·December 1, 2009

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·December 1, 2009

    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code LWP·April 29, 2014

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·March 23, 2009