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Medtronic Vascular Galway DBA Medtronic Ireland recalls Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X,
Recalled October 23, 2019 · FDA recall Z-0123-2020 · Medtronic Vascular Galway
Hazard
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. · FDA Class II
Units
98675 units
Sold at
worldwide
Description
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Product
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)
Manufacturer(s)
Medtronic Vascular Galway DBA Medtronic Ireland
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →