Medtronic Vascular Galway DBA Medtronic Ireland
Medtronic Vascular Galway DBA Medtronic Ireland appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2039-2020, Class I) was initiated on May 12, 2020.
Summary
- Total Recalls
- 5 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2039-2020 | Class I | Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices int | May 12, 2020 |
| Z-0122-2020 | Class II | Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, | September 3, 2019 |
| Z-0123-2020 | Class II | Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, | September 3, 2019 |
| Z-3137-2017 | Class II | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplast | July 13, 2017 |
| Z-3136-2017 | Class II | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty | July 13, 2017 |