Medtronic Ireland
GALWAY Galway, IE
MEDTRONIC IRELAND appears in FDA device records in GALWAY Galway, IE. FDA records list 9 510(k) clearances between and , 243 PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Medtronic Ireland carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medtronic Vascular Galway DBA Medtronic Irelandenforcement report, recall
- Medtronic Vascular Galway Limitedrecall
510(k) clearance history
FDA records hold 9 510(k) clearances for Medtronic Ireland between 2006 and 2026. The busiest year on record is 2026, with 3. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2010 | 1 |
| 2013 | 1 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | LOX | Substantially Equivalent | |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | LOX | Substantially Equivalent | |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | LOX | Substantially Equivalent | |
| K252390 | Telescope Guide Extension Catheter | DQY | Substantially Equivalent | |
| K250787 | Liberant Thrombectomy System | QEW | Substantially Equivalent | |
| K123153 | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT | DQY | Substantially Equivalent | |
| K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON | LOX | Substantially Equivalent | |
| K061480 | ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM | DQY | Substantially Equivalent | |
| K053431 | ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9612164 | 3002806434 | MEDTRONIC IRELAND | PARKMORE BUSINESS PARK WEST, GALWAY Galway(County) -- IE | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QYIAblation Catheter, Renal Denervation
- PJQAgent, Occluding, Vascular, Permanent
- NPTAortic Valve, Prosthesis, Percutaneously Delivered
- DQYCatheter, Percutaneous
- OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- MCWCatheter, Peripheral, Atherectomy
- DRACatheter, Steerable
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- NIQCoronary Drug-Eluting Stent
- PRCDrug-Coated Peripheral Transluminal Angioplasty Catheter
- ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter
- OTDEndovascular Suturing System
- DYBIntroducer, Catheter
- PNJLeadless Pacemaker
- OSRPacemaker/Icd/Crt Non-Implanted Components
- QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- QEWPeripheral Mechanical Thrombectomy With Aspiration
- NPVPulmonary Valve Prosthesis Percutaneously Delivered
- JXGShunt, Central Nervous System And Components
- MAFStent, Coronary
- NIOStent, Iliac
- MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2039-2020 | Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. | Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) | Class I | Terminated | |
| Z-0123-2020 | Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY) | Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. | Class II | Open, Classified | |
| Z-0122-2020 | Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X | Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. | Class II | Open, Classified | |
| Z-3137-2017 | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Terminated | |
| Z-3136-2017 | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Terminated | |
| Z-1367-2011 | 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. | The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and Instructions For Use. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain