Recall Z-2023-2012
EKOS Corporation · initiated May 24, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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…
Reason for recall
EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking during insertion or operation.
FDA-determined cause: Device Design
Action taken
Starting May 25, 2012 to May 31, 2012, EKOS Corporation sent "New warnings in EkoSonic Endovascular Device Instruction for Use" letter, dated May 24, 2012, to all affected customers. Attached with the notification letter is the revised EKOS MACH4 Endovascular Device Instructions for Use in Peripheral Vasculature. Customers are informed of the complaints about the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and reports of the MicroSonic Device (MSD) breaking during insertion or operation. Customers with questions about the revised Instruction for Use, please contact EKOS Corporation at 425-415-3132.
Details
- Recall number
- Z-2023-2012
- Initiated
- May 24, 2012
- Posted by FDA
- July 17, 2012
- Terminated
- November 20, 2012
- Product code
- KRA – Catheter, Continuous Flush
- Quantity
- 21,892 units
- Distribution
- 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…
- Recalling firm
- EKOS Corporation, Bothell, WA