Mermaid Medical A/S: Medical Device Recall in 2024 - (Recall #: Z-2213-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 1, 2024

Date Posted: July 3, 2024

Recall Number: Z-2213-2024

Event ID: 94741

Reason for Recall:

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

Status: Ongoing

Product Quantity: 190 devices

Code Information:

Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065

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.

Voluntary or Mandated:

Voluntary: Firm initiated