Question 1

Is 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 recalled?

Accepted Answer

Mermaid Medical A/S is recalling 190 units of the D*Clot HD Rotational Thrombectomy System, a 6 French catheter used to break up blood clots. Internal testing revealed that the packaging failed bubble leak tests, which means the sterile barrier may be compromised. This recall affects Model Number T10106065 and Lot S2306001, which were distributed across 13 US states and Chile. Consumers and healthcare providers should identify these specific units and contact the manufacturer for further instructions.

Question 2

What should I do?

Accepted Answer

Immediately check your medical inventory for the D*Clot HD Rotational Thrombectomy System with Model Number T10106065 and Lot code S2306001. Verify the Unique Device Identifier (UDI) 15711055004333 on the product packaging to confirm if your device is part of the affected batch. Do not use any devices identified as belonging to the recalled lot, as they may no longer be sterile. Contact your healthcare provider or Mermaid Medical A/S at their headquarters in Stenlose, Denmark, for instructions on returning the affected devices and receiving potential replacements or refunds. For additional information or to report concerns, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or the manufacturer for further instructions and potential refund

Mermaid Medical A/S: D*Clot HD Rotational Thrombectomy System Recalled for Sterility Failure

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

Were You Affected by This Recall?