Drug recall
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X…
FDA recall event 83797 · Class II · Medtronic Vascular Galway DBA Medtronic Ireland
Key facts
| Event ID | 83797 |
|---|---|
| Recall numbers | Z-0122-2020, Z-0123-2020 |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland |
| Product type | Devices |
| Products | Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X…, Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. |
| Initiation date | Sep 3, 2019 |
| Report date | Oct 23, 2019 |
| City | Galway |
| Country | Ireland |
| FEI number | 3002806434 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: