The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.
Enforcement
- Recall Number
- Z-2213-2024
- Event ID
- 94741
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mermaid Medical A/S
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 3, 2024
- Initiation Date
- May 1, 2024
- Classification Date
- June 26, 2024
- Address
- Frydensbergvej 25, Stenlose, N/A, Denmark
Description
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065
Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the country of Chile.
190 devices