Mermaid Medical A/S: Device Recall

Recall #Z-2213-2024 · 05/01/2024

Class II: Risk

Recall Details

Recall Number: Z-2213-2024
Classification: Class II
Product Type: Device
Recalling Firm: Mermaid Medical A/S
Status: Ongoing
Date Initiated: 05/01/2024
Location: Stenlose, Denmark
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 190 devices

Reason for Recall

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

Product 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.

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.