Drug recall
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French…
FDA recall event 94741 · Class II · Mermaid Medical A/S
Key facts
| Event ID | 94741 |
|---|---|
| Recall numbers | Z-2213-2024 |
| Recalling firm | Mermaid Medical A/S |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. |
| Initiation date | May 1, 2024 |
| Report date | Jul 3, 2024 |
| City | Stenlose |
| Country | Denmark |
| FEI number | 3007146453 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: