EKOS MACH4 Endovascular Device Recalled for Catheter Marker Dislodgement
EKOS Corporation is recalling EkoSonic MACH4 Endovascular Devices because radio-opaque marker bands may dislodge and the MicroSonic Device may break during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with mechanical defects (dislodged markers and breaking components) that pose a risk of harm during procedures, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
EKOS Corporation is recalling the EkoSonic MACH4 Endovascular Device, a catheter system used for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The recall involves 21,892 units distributed worldwide, including in the United States and numerous international markets.
The recall was initiated after the manufacturer received complaints that radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during procedures. Additionally, there were reports of the MicroSonic Device (MSD) breaking during insertion or operation. These mechanical failures could compromise the device's function and safety during medical procedures.
Healthcare providers and facilities that have used or possess these devices should stop using them immediately. EKOS Corporation is the recalling firm and is responsible for managing the recall actions. Users should contact EKOS Corporation for further instructions on how to return or dispose of the affected units.
The recalled product
- 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 MicroSo
- Manufacturer
- EKOS Corporation
- Affected units
- 21,892
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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