Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters used in heart procedures worldwide due to difficulties removing the stylette (a component of the device). Approximately 69,081 units were distributed in the US, with additional distribution across numerous countries globally. The recalled products are identified by specific product numbers and lot codes listed in the recall notice.
The recall notice does not specify a remedy or recommended consumer action. Consumers should contact Medtronic or their healthcare provider for guidance regarding recalled devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Stylette removal difficulties on the Euphora and Solarice products.
Reason for recall: Stylette removal difficulties on the Euphora and Solarice products. Distribution: Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, Quantity: 69,081 (US) Lot/code info: Product Number/CFN GTIN Lot EUP22512X 00643169559950 212561150 EUP3015X 00643169560154 212561157 EUP1512X 00643169559837 212561158 EUP1515X 00643169559844 212561152 EUP3015X 00643169618916 212572601 EUP2012X 00643169618527 212572603 EUP2520X 00643169560031 212572479 EUP1510X 00643169618633 212572600 EUP2512X 00643169560017 212572471 EUP22515X 00643169559967 212572472 EUP1515X 00643169618688 212577123 EUP2020X 00643169618442 212577128 EUP27520X 00643169560109 212572474 EUP3020X 00643169560161 212572476 EUP1520X 00643169618923 212577129 EUP2512X 00643169618817 212577127 EUP27515X 00643169618855 212553130 EUP2506X 00643169559998 212572475 EUP2510X 00643169560000 212577156 EUP2510X 00643169618732 212577125 EUP2012X 00643169618527 212577130 EUP2015X 00643169618480 212577124 EUP2010X 00643169618862 212577131 EUP2020X 00643169559905 212610574 EUP2512X 00643169560017 212577157 EUP3012X 00643169560147 212577155 EUP2006X 00643169559868 212577159 EUP27515X 00643169560093 212572477 EUP27512X 00643169560086 212577158 EUP2010X 00643169559875 212610579 EUP3515X 00643169560284 212572478 EUP2006X 00643169559868 212610578 EUP22520X 00643169559974 212610565 EUP22512X 00643169559950 212610575 EUP22510X 00643169559943 212610572 EUP3010X 00643169560130 212610518 EUP3006X 00643169560123 212610566 EUP3520X 00643169560291 212610564 EUP2512X 00643169560017 212613013 EUP2520X 00643169560031 212613011 EUP1506X 00643169559813 212577780 EUP1515X 00643169559844 212610576 EUP2030X 00643169559929 212610567 E
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.