Mermaid Medical A/S recalls The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The dispos…

Recall date

May 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2213-2024

FDA classification

Class II

Brand / firm

Mermaid Medical A/S

Sold / distributed

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.

Why it was recalled

Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.