Medtronic Vascular Galway DBA Medtronic Ireland

FDA Regulatory Profile

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

medtronic ireland, medtronic, ireland

Recent Recalls

NumberClassProductDate
Z-2039-2020Class IMedtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices intMay 12, 2020
Z-0122-2020Class IIEuphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X,September 3, 2019
Z-0123-2020Class IISolarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X,September 3, 2019
Z-3137-2017Class IISolarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary AngioplastJuly 13, 2017
Z-3136-2017Class IIEuphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary AngioplastyJuly 13, 2017