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

Recalled July 3, 2024 · FDA recall Z-2213-2024 · Mermaid Medical A/S

Hazard

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

Units

190 devices

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Mermaid Medical A/S

Made in

Denmark

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →