FDAFDA · Food and drugs·Recall number Z-0123-2020
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)
Published October 23, 2019 · Recall initiated: September 3, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Vascular Galway DBA Medtronic Ireland
- Distributor
- worldwide
- Lot
- Product Number / CFN GTIN Lot SLC1506X 00643169680005 217427355 SLC1510X 00643169680012 217253572 SLC1510X 00643169680012 217298666 SLC1510X 00643169680012 217387126 SLC1510X 00643169680012 217427354 SLC1510X 00643169680012 217487816 SLC1512X 00643169680029 217218112 SLC1512X 00643169680029 217253582 SLC1512X 00643169680029 217387128 SLC1512X 00643169680029 217487818 SLC1512X 00643169680029 217542634 SLC1512X 00643169680029 217859789 SLC1515X 00643169680036 217246455 SLC1515X 00643169680036 217253577 SLC1515X 00643169680036 217306789 SLC1515X 00643169680036 217415822 SLC1515X 00643169680036 217427365 SLC1515X 00643169680036 217823443 SLC1515X 00643169680036 217859165 SLC1515X 00643169680036 217940024 SLC1520X 00643169680043 217253580 SLC1520X 00643169680043 217306787 SLC1520X 00643169680043 217427359 SLC1520X 00643169680043 217542633 SLC1520X 00643169680043 217646425 SLC1520X 00643169680043 217668582 SLC1520X 00643169680043 217799249 SLC1520X 00643169680043 217859164 SLC2006X 00643169680050 217435326 SLC2006X 00643169680050 217913786 SLC2010X 00643169680067 217253573 SLC2010X 00643169680067 217297545 SLC2010X 00643169680067 217387127 SLC2010X 00643169680067 217427356 SLC2010X 00643169680067 217646867 SLC2010X 00643169680067 217668585 SLC2010X 00643169680067 217676631 SLC2010X 00643169680067 217905820 SLC2012X 00643169680074 217253578 SLC2012X 00643169680074 217298670 SLC2012X 00643169680074 217306788 SLC2012X 00643169680074 217415824 SLC2012X 00643169680074 217434925 SLC2012X 00643169680074 217602539 SLC2012X 00643169680074 217668687 SLC2012X 00643169680074 217799250 SLC2012X 00643169680074 217859791 SLC2012X 00643169680074 217940066 SLC2015X 00643169680081 217218115 SLC2015X 00643169680081 217253574 SLC2015X 00643169680081 217271254 SLC2015X 00643169680081 217298669 SLC2015X 00643169680081 217306223 SLC2015X 00643169680081 217404046 SLC2015X 00643169680081 217418812 SLC2015X 00643169680081 217418907 SLC2015X 00643169680081 217427706 SLC2015X 00643169680081 217435327 SLC2015X 00643169680081 217498815 SLC2015X 00643169680081 217615647 SLC2015X 00643169680081 217646871 SLC2015X 00643169680081 217668584 SLC2015X 00643169680081 217713076 SLC2015X 00643169680081 217721607 SLC2015X 00643169680081 217777612 SLC2015X 00643169680081 217799251 SLC2015X 00643169680081 217884509 SLC2015X 00643169680081 217913790 SLC2020X 00643169680098 217218110 SLC2020X 00643169680098 217246457 SLC2020X 00643169680098 217253575 SLC2020X 00643169680098 217271253 SLC2020X 00643169680098 217298667 SLC2020X 00643169680098 217306220 SLC2020X 00643169680098 217387130 SLC2020X 00643169680098 217404047 SLC2020X 00643169680098 217418908 SLC2020X 00643169680098 217487822 SLC2020X 00643169680098 217498821 SLC2020X 00643169680098 217676628 SLC2020X 00643169680098 217713075 SLC2020X 00643169680098 217727927 SLC2020X 00643169680098 217799252 SLC2020X 00643169680098 217850364 SLC2020X 00643169680098 217905822 SLC2025X 00643169680104 217271251 SLC2025X 00643169680104 217542635 SLC2025X 00643169680104 217905821 SLC2030X 00643169680111 217218119 SLC2030X 00643169680111 217427363 SLC2030X 00643169680111 217602538 SLC2030X 00643169680111 217704778 SLC2030X 00643169680111 217777614 SLC22510X 00643169680135 217487815 SLC22510X 00643169680135 217646423 SLC22515X 00643169680159 217427362 SLC22515X 00643169680159 217646422 SLC22520X 00643169680166 217721606 SLC22520X 00643169680166 217913787 SLC22525X 00643169680173 217415820 SLC22525X 00643169680173 218025488 SLC2506X 00643169680180 217823441 SLC2510X 00643169680197 217218122 SLC2510X 00643169680197 217401003 SLC2510X 00643169680197 217427357 SLC2510X 00643169680197 217693881 SLC2510X 00643169680197 217913792 SLC2510X 00643169680197 218034774 SLC2512X 00643169680203 217271257 SLC2512X 00643169680203 217306225 SLC2512X 00643169680203 217415825 SLC2512X 00643169680203 217434924 SLC2512X 00643169680203 217498822 SLC251
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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