Recall Z-2213-2024
Mermaid Medical A/S · initiated May 1, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065
Reason for recall
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
FDA-determined cause: Under Investigation by firm
Action taken
The consignees and distributors were sent out the notification via email on 05/01/2024. The letter instructs the consignees to: 1. Quarantine and Discontinue Use of Affected Product: Identify, segregate, and discontinue use of the affected product in your inventory. 2. Complete and Return the attached Response Form: Complete the attached Response Form and return to Mermaid Medical by May 10, 2024 via email or by post. 3. Distributors/ If You Further Distributed Affected Product: Forward this communication to any customers that were distributed affected product. Instruct any of your customers to complete the response form and return to Mermaid Medical. Once they complete and return the response form, Mermaid Medical will provide instructions on how to return or destroy any affected product remaining in their inventory.
Details
- Recall number
- Z-2213-2024
- Initiated
- May 1, 2024
- Posted by FDA
- June 26, 2024
- Product code
- QEW – Peripheral Mechanical Thrombectomy With Aspiration
- Quantity
- 190 devices
- Distribution
- 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.
- Recalling firm
- Mermaid Medical A/S, Stenlose