Recall Z-2213-2024— Mermaid Medical A/S

Name: FDA recall Z-2213-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-01

Class II · Ongoing

Class II FDA medical device recall by Mermaid Medical A/S, initiated 2024-05-01. It names one FDA 510(k) clearance: K021641. 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: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact..

Recalling firm: Mermaid Medical A/S
Classification: Class II
Status: Ongoing
Initiated: 2024-05-01
Firm location: Stenlose, Denmark

510(k) clearances named in this recall

1 on FDA's record

K021641 — XTD THROMBECTOMY CATHETER, XX CMXtrak Medical, Inc.·cleared 2002-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.