Device recall
Z-0122-2020: Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X…
FDA device recall · Class II · Medtronic Vascular Galway DBA Medtronic Ireland
Key facts
| Recall number (Z-number) | Z-0122-2020 |
|---|---|
| Recall event | 83797 |
| Product | 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… |
| Product code | LOX |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K143480 |
| FEI number | 3002806434 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database