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    FDA Adverse Event
    Malfunction ·MEDTRONIC ATS MEDICAL, INC.·Product code LWR·January 25, 2012

    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code LWQ·February 11, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Recall
    Terminated ·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020

    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·April 1, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    FDA Enforcement
    Class II ·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020

    Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·February 11, 2010

    Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead Kit Manufactured at : Medtronic, Inc., Villalba, Puerto Rico, STIMLOC Burr Hole Kit: Manufacturer: Medtronic Image-Guided Neurologics, Melbourne, FL 32935-3145 Implant manual: DBS Leads: Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor control system is indicated for the suppression of tremor in the upper extremity. The system is intended for using patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·June 14, 2008

    Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead Kit Manufactured at : Medtronic, Inc., Villalba, Puerto Rico, STIMLOC Burr Hole Kit: Manufacturer: Medtronic Image-Guided Neurologics, Melbourne, FL 32935-3145 Implant manual: DBS" Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor control system is indicated for the suppression of tremor in the upper extremity. The system is intended for using patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·June 14, 2008

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

    INPEN MMT-105ELPKNA ELI LILY PINK

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 1, 2021

    INPEN MMT-105ELBLNA ELI LILY BLUE

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

    INPEN MMT-105ELBLNA ELI LILY BLUE

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

    INPEN MMT-105ELPKNA ELI LILY PINK

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021