FDA Device recall Z-2213-2024
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French
- FDA Device
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French by Mermaid Medical A S, citing internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2213-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-01 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mermaid Medical A S |
| Distribution | US |
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
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Identifiers
| code_info | Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2213-2024%22
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