FDA-Device2019-10-23Class II
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, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SL
Medtronic Vascular Galway DBA Medtronic Ireland
Hazard
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Sold states
worldwide
Affected count
98675 units
Manufactured in
Parkmore Business Park West, N/A, Galway, N/A, Ireland
Products
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, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2020Don't want to check this manually?
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