Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2
Check against the official notice below — it lists the full affected range.
Medtronic Vascular Galway has recalled 53,137 units of Euphoria Rapid Exchange Balloon Dilatation Catheters worldwide across six product numbers (EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, and EUP2006X, EUP2010X, EUP2012X). The catheters are being recalled because some units have a slightly higher diameter stylette that causes difficulty during removal.
The recall record 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: 53137 units Lot/code info: Product Number / CFN GTIN Lot EUP1506X 00643169559813 217238068 EUP1506X 00643169618695 217291131 EUP1506X 00643169559813 217354645 EUP1506X 00643169979475 217473721 EUP1506X 00643169618695 217473914 EUP1506X 00643169979475 217506615 EUP1506X 00643169979475 217576082 EUP1506X 00643169559813 217638054 EUP1506X 00643169559813 217833021 EUP1506X 00643169979475 217876349 EUP1510X 00643169559820 217225186 EUP1510X 00643169559820 217238070 EUP1510X 00643169618633 217262907 EUP1510X 00643169559820 217371289 EUP1510X 00643169979413 217396792 EUP1510X 00643169979413 217451079 EUP1510X 00643169979413 217473910 EUP1510X 00643169618633 217473911 EUP1510X 00643169979413 217518609 EUP1510X 00643169559820 217602408 EUP1510X 00643169559820 217610624 EUP1510X 00643169618633 217630776 EUP1510X 00643169559820 217656465 EUP1510X 00643169618633 217704793 EUP1510X 00643169979413 217704794 EUP1510X 00643169979413 217803293 EUP1510X 00643169559820 217804976 EUP1510X 00643169979413 217817346 EUP1510X 00643169979413 217939845 EUP1510X 00643169979413 217960062 EUP1512X 00643169979338 217282165 EUP1512X 00643169559837 217282749 EUP1512X 00643169559837 217290758 EUP1512X 00643169618558 217291003 EUP1512X 00643169618558 217396342 EUP1512X 00643169979338 217451080 EUP1512X 00643169559837 217518423 EUP1512X 00643169979338 217584296 EUP1512X 00643169618558 217728406 EUP1512X 00643169559837 217791032 EUP1512X 00643169618558 217803295 EUP1512X 00643169979338 217817347 EUP1512X 00643169559837 217833023 EUP1512X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.