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    MEDTRONIC IRELAND

    FDA registration
    MEDTRONIC IRELAND·21 products·🇮🇪 Ireland

    ONYX

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·March 27, 2025

    AXIUM

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·March 27, 2025

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 26, 2025

    PIPELINE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 26, 2025

    Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular, Inc.·November 13, 2013

    MEDTRONIC VALIANT STENT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·March 27, 2024

    MEDTRONIC VALIANT STENT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·March 27, 2024

    Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code NIQ·October 7, 2013

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 29, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·April 27, 2026

    INSET GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·May 1, 2026

    INSET GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·April 10, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 31, 2026

    INSET GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·May 6, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·April 27, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 31, 2026

    CH HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 22, 2020

    Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.

    FDA Recall
    Terminated ·Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland·Product code NIQ·August 6, 2009

    Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432 USA. The Medtronic Attain Access Model 6218A Left-heart delivery system is designed to facilitate lead implantation in the left heart, via the coronary sinus. The Left-heart delivery system features one guide wire to facilitate venous access, an adjustable valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters and appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code DQY·August 27, 2008