BEUDAMED
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    EXTERNAL NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·July 29, 2019

    EXTERNAL NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·July 29, 2019

    GEM

    FDA Adverse Event
    Malfunction ·MW MOONEY & CO. INC.·Product code FNS·May 25, 2004

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·MFG FACILITY (INITIAL MW): LEEDS·Product code JDI·May 17, 2017

    RESTORE PRIME

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 1, 2013

    SYNERGY VERSITREL

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 28, 2016

    SYNERGY VERSITREL

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 24, 2015

    DELTA CER HEAD 12/14 32MM +1

    FDA Adverse Event
    Injury ·DEPUY IRELAND MFG FACILITY (INITIAL MW): IRELAND·Product code LZO·October 10, 2014

    EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·June 17, 2024

    Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·November 4, 2021

    Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code EZW·June 25, 2007

    Medtronic InterStim Ground Pad REF 041826

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·July 6, 2023

    Enhanced Verify Evaluation Handset (CFN HH90130FA)

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·April 3, 2025

    InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·May 15, 2019

    C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CZW·May 16, 2018

    Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code EZW·May 12, 2008

    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·February 28, 2022

    Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code EZW·June 25, 2007