Brand
Mermaid Medical A/S
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Mermaid Medical A/S and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-07-03FDA-DeviceClass IIThe 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
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
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