# FDA recall Z-2213-2024

> **Mermaid Medical A/S** · Class II · device recall initiated 2024-05-01.

## 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.

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-2213-2024
- **Recalling firm:** Mermaid Medical A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-01
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stenlose, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2024

## Citation

> AI Analytics. FDA recall Z-2213-2024. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-2213-2024. Source: US FDA. Licensed CC0.

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