EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.

Recall details

Manufacturer

EKOS Corporation

Distributor

Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, Republic of Ireland, Slovenia, Costa Rica, Argentina, Brazil, Dominican Republic, Taiwan, Korea, Greece, Mexico, Italy, Uruguay, Paraquay, Yugoslavia, New Zealand, India, Venezuela, South America, Norway, Sweden, Denmark, Turkey, Great Britain, Israel, Spain, Portugal, Greece, Korea, China, and Japan.

Lot

Serial Numbers: 090220013-001; 090323005-001; 090415007-001; 090416010-003; 090421002-001; 090421002-003; 090422005-001; 090422005-002; 090422005-004; 090422006-001; 090422006-002; 090422006-003; 090422006-004; 090422006-005; 090422006-006; 090422007-005; 090423002-001; 090423006-001; 090423006-002; 090423007-001; 090423007-002; 090423007-003; 090423007-004; 090423007-005; 090423007-006; 090423007-007; 090423008-001; 090423008-002; 090423008-003; 090423008-004; 090423008-005; 090423008-006; 090423008-008; 090427001-001; 090427001-002; 090427001-003; 090427001-004; 090427001-005; 090427006-003; 090427006-004; 090427007-001; 090427007-002; 090427008-001; 090427008-002; 090427008-003; 090428006-001; 090428006-002; 090428007-001; 090428008-004; 090428008-005; 090428008-006; 090429004-001; 090429004-002; 090429004-003; 090429004-004; 090429004-005; 090429004-006; 090429005-002; 090429006-001; 090429006-002; 090429011-002; 090429011-004; 090429011-005; 090429021-001; 090429021-002; 090429021-003; 090429021-004; 090429022-002; 090429023-001; 090429023-002; 090429023-003; 090430007-001; 090430007-002; 090430007-003; 090430007-004; 090430008-001; 090430009-001; 090430009-002; 090430009-003; 090430009-004; 090430010-001; 090430010-002; 090430010-003; 090430011-001; 090430011-002; 090430011-003; 090430011-005; 090430012-001; 090430012-002; 090430012-003; 090430012-004; 090430013-001; 090430013-002; 090430014-001; 090430014-002; 090430014-003; 090430014-004; 090430014-005; 090430015-001; 090430015-002; 090430015-003; 090430024-001; 090430031-001; 090430031-002; 090430031-003; 090430031-004; 090430031-005; 090430031-006; 090504008-001; 090504008-002; 090504008-003; 090504008-004; 090504008-005; 090504009-001; 090504009-002; 090504009-003; 090504009-004; 090504009-005; 090504009-006; 090504009-007; 090504009-008; 090504009-009; 090504011-001; 090504012-001; 090504012-002; 090504012-003; 090504012-004; 090504013-001; 090504013-002; 090504013-003; 090504013-004; 090504014-001; 090504014-002; 090504014-003; 090504014-004; 090504015-001; 090504015-002; 090504015-003; 090504015-004; 090504016-001; 090504016-002; 090504016-003; 090505006-001; 090505007-001; 090505007-002; 090505007-003; 090505007-004; 090505007-005; 090505007-006; 090505007-007; 090505007-008; 090505007-009; 090505008-001; 090505008-002; 090505009-001; 090505009-002; 090505009-003; 090505009-004; 090505009-005; 090505010-001; 090505010-002; 090505010-003; 090505011-001; 090505011-002; 090505012-001; 090505012-002; 090505012-003; 090505013-001; 090505013-002; 090505013-003; 090505013-004; 090505013-005; 090505028-001; 090505028-002; 090505028-003; 090505029-001; 090505029-002; 090505029-003; 090505030-001; 090505030-002; 090505030-003; 090505031-001; 090505031-002; 090505031-003; 090505031-004; 090505031-005; 090506007-002; 090506007-003; 090506007-004; 090506008-001; 090506008-002; 090506008-003; 090506008-004; 090506009-001; 090506009-002; 090506010-001; 090506010-002; 090506011-001; 090506011-002; 090506011-003; 090506011-004; 090506012-001; 090506012-002; 090506012-003; 090506012-004; 090506020-001; 090506020-002; 090506020-003; 090506020-004; 090506021-001; 090506021-002; 090506021-003; 090506021-004; 090506021-005; 090506022-003; 090506022-004; 090506022-006; 090506022-007; 090506022-008; 090506022-010; 090506022-011; 090506022-019; 090506022-020; 090506022-021; 090506022-022; 090506022-023; 090506022-024; 090506022-025; 090506022-026; 090506022-027; 090506022-028; 090506022-029; 090506022-030; 090506022-031; 090506022-032; 090506022-033; 090506022-035; 090506023-001; 090506023-002; 090506023-003; 090506023-004; 090506023-005; 090507001-001; 090507001-002; 090507001-003; 090507001-004; 090507001-005; 090507001-006; 090507002-001; 090507003-001; 090507003-002; 090507003-003; 090507003-004; 090507003-005; 090507003-006; 090507004-001; 090507004-002; 090507004-003; 090507004-004; 090507004-005; 090507004-006; 090507005-001; 090507005-002; 090507005-003; 090507006-001; 09050700

Risk classification

Class II

Area (FDA)

device

Country

United States