BEUDAMED
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    Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·December 23, 2020

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·April 25, 2017

    Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·November 19, 2020

    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·April 14, 2021

    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·March 9, 2021

    CARELINK PROGRAMMER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 26, 2021

    TECNIS SYMFONY

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·July 23, 2019

    FREESTYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code QLG·April 16, 2024

    TECNIS SYMFONY

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·August 20, 2019

    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·September 24, 2024

    PERCEPT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code PJS·July 24, 2024

    PERCEPT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 12, 2024

    PERCEPT RC V1

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 30, 2024

    SYSTEM 002-1100 15W THERMAL THERAPY

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code GEX·March 10, 2017

    PERCEPT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·November 4, 2024

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 9, 2015

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code QCB·January 14, 2020

    NUCLEUS 22

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·April 29, 2026

    TACTILE GUIDANCE SYSTEM V. 2.0

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code HAW·April 13, 2011

    ANATOMAGE GUIDE

    FDA Adverse Event
    Injury ·ANATOMAGE INC.·Product code NDP·June 1, 2015