Recall Z-2023-2012 ยท KRA Catheter, Continuous Flush
EKOS Corporation
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 th
| Date | Jul 17, 2012 (initiated May 24, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 rev |
| 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, Gree |
| FDA record | Open on fda.gov |