Recall Z-0123-2020 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Medtronic Vascular Galway DBA Medtronic Ireland
Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SL
| 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 | 98675 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.