Z-2213-2024 Class II Ongoing
FDA device recall Z-2213-2024 was initiated by Mermaid Medical A/S on May 1, 2024 and is designated Class II. Reason for recall: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. The recall status is ongoing. Affected quantity: 190 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2024
- Initiation Date
- May 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 devices
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the country of Chile.
Code Information
Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065