Reported Jul 3, 2024 · Ongoing
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The…
Mermaid Medical A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mermaid Medical A/S · Frydensbergvej 25 · Stenlose · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Unique Device Identifier15711055004333
- Lot codesS2306001
- Model NumberT10106065
- Amount recalled
- 190 devices
Where it was sold
Why it was recalled
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
This product could cause temporary or reversible health problems — stop using it.
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