EkoSonic MACH4 Endovascular Device — Class II medical device recall Z-2023-2012
Terminated recall by EKOS Corporation, reported 2012-07-25, distributed in KY, OH, TN. EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on t
| Recall number | Z-2023-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EKOS Corporation, Bothell, WA, United States |
| Recall initiated | 2012-05-24 |
| Classified | 2012-07-17 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2012-11-20 |
| Distributed | KY, OH, TN |
| Countries outside the US | AR, AT, BE, BR, CH, CN, CR, CZ, DE, DK, DO, ES, GB, GR, IE, IL, IN, IT, JP, KR, LU, MX, NL, NO, NZ, PL, PT, SE, SI, SK, TR, TW, UY, VE |
| Quantity | 21,892 units |
| Serial numbers | 090, 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 and 475 more |
| Model numbers | 500-55106, 500-55112, MACH4 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2023-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.