The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous… — Class II medical device recall Z-2213-2024
Ongoing recall by Mermaid Medical A/S, reported 2024-07-03, distributed nationwide. Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may no
| Recall number | Z-2213-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mermaid Medical A/S, Stenlose, Denmark |
| Recall initiated | 2024-05-01 |
| Classified | 2024-06-26 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL |
| Quantity | 190 devices |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 15711055004333 |
| Lot numbers | S2306001 |
| Model numbers | T10106065 |
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.
Reason for recall
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2213-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.