Mermaid Medical recalls D*Clot HD Rotational Thrombectomy System due to potential sterility barrier failure. Internal testing showed bubble leak issues, risking contamination during procedures. Affected units have model T10106065 and lot S2306001.
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Mermaid Medical is recalling its D*Clot HD Rotational Thrombectomy System because internal testing found it may not maintain sterility properly. This could lead to infections during medical procedures if the device is used without a fully intact sterility barrier.
The device's sterility barrier might not be fully intact due to bubble leak testing failures. This could allow contamination during medical procedures, potentially leading to infections if the device is used without proper sterility.
Healthcare professionals using the D*Clot HD system for thrombectomy procedures are most at risk. Patients undergoing these procedures may be affected if the device fails to maintain sterility.
Check for model number T10106065 and lot code S2306001 on the device packaging. The system is a percutaneous catheter-based device used in thrombectomy procedures.
Look for model number T10106065 and lot code S2306001 on the device packaging.
Internal product testing failed bubble leak testing (ASTM F2096), indicating the sterility barrier may not be fully intact.
The sterility barrier might not be fully intact, which could lead to contamination during medical procedures and potential infections.
Check for model number T10106065 and lot code S2306001 on the device packaging.
We’ve drafted a message you can send Mermaid Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2213-2024 — Mermaid Medical Mermaid Medical Hello, I own a Mermaid Medical that is covered by recall Z-2213-2024 from Mermaid Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
