FDA Device recall Z-2023-2012

EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112

FDA Device
Class II
terminated
Published 2012-07-25

On 2012-07-25 the FDA classified a Class II recall of EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112 by Ekos, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2023-2012
Classification	Class II
Status	terminated
Initiated	2012-05-24
Published	2012-07-25
Last updated	2026-09-13 11:53 UTC
Company	Ekos
Distribution	KY, OH, TN

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

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.

Identifiers

code_info	Serial Numbers: 090220013-001; 090323005-001; 090415007-001; 090416010-003; 090421002-001; 090421002-003; 090422005-00… 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; 09042902

code_info

Serial Numbers: 090220013-001; 090323005-001; 090415007-001; 090416010-003; 090421002-001; 090421002-003; 090422005-00…

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; 09042902

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2023-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.