Recall Z-2213-2024 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Mermaid Medical A/S
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
| Date | Jun 26, 2024 (initiated May 1, 2024) |
| Status | Open, Classified |
| Reason | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021641 | XTD THROMBECTOMY CATHETER, XX CM Xtrak Medical, Inc., Jul 26, 2002 |