Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based Recalled by Mermaid Medical A/S Due to Internal product testing failed bubble leak testing (ASTM...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mermaid Medical A/S directly.
Affected Products
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.
Quantity: 190 devices
Why Was This Recalled?
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mermaid Medical A/S
Mermaid Medical A/S has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report