Recall Z-0122-2020 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Medtronic Vascular Galway DBA Medtronic Ireland
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, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP300
| Date | Sep 3, 2019 |
| Status | Open, Classified |
| Reason | Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. |
| Root cause | Under Investigation by firm |
| Action | Medtronic notified it consignees by letter beginning on 09/03/2019. The firm requested the return of the affected product. |
| Quantity | 53137 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter Medtronic, Inc., Apr 2, 2015 |