Medtronic Ireland
PARKMORE BUSINESS PARK WEST, GALWAY, IE
Registered product codes
21 product codes
Recent MDR events
66,138 on file
- Micra¿ AV2Jul 31, 2026Malfunction9612164-2026-03859
- Micra¿ AV2Jul 31, 2026Death9612164-2026-03860
- Micra¿ AV2Jul 31, 2026Malfunction9612164-2026-03861
- Micra¿ AV2Jul 31, 2026Injury9612164-2026-03862
- Micra¿ VR2Jul 31, 2026Malfunction9612164-2026-03863
- Valiant Captivia - FFJul 31, 2026Malfunction9612164-2026-03864
- VALIANT CAPTIVIAJul 31, 2026Malfunction9612164-2026-03865
- VALIANT CAPTIVIAJul 31, 2026Injury9612164-2026-03866
- ENDURANT II STENT GRAFTJul 31, 2026Malfunction9612164-2026-03867
- ENDURANT II STENT GRAFTJul 31, 2026Injury9612164-2026-03868
Recalls
5 on file
- TerminatedMay 27, 2020
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
View FDA record ↗ - TerminatedSep 20, 2017
Stylette removal difficulties on the Euphora and Solarice products.
View FDA record ↗ - TerminatedSep 20, 2017
Stylette removal difficulties on the Euphora and Solarice products.
View FDA record ↗ - Open, ClassifiedUnknown
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
View FDA record ↗ - Open, ClassifiedUnknown
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
View FDA record ↗
Compliance history
Matched by FEI 3002806434.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.