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, SLC253
Check against the official notice below — it lists the full affected range.
Medtronic Vascular Galway has recalled approximately 98,675 units of Solarice Rapid Exchange Balloon Dilatation Catheters distributed worldwide. The catheters were recalled because some units have a slightly higher diameter stylette that causes removal difficulties during use.
The affected product numbers are SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, and SLC2012X. Specific lot numbers for each product are identified in the recall notice. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Reason for recall: Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. Distribution: worldwide Quantity: 98675 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.