Device recall
Z-2213-2024: The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based…
FDA device recall · Class II · Mermaid Medical A/S
Key facts
| Recall number (Z-number) | Z-2213-2024 |
|---|---|
| Recall event | 94741 |
| 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… |
| Product code | QEW |
| Recalling firm | Mermaid Medical A/S |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K021641 |
| FEI number | 3007146453 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database