The D*Clot HD Rotational Thrombectomy System is a… recallZ-2213-2024 · Mermaid Medical A/S · initiated May 1, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mermaid Medical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
FDA root cause category: Under Investigation by firm
What the company is doing
The consignees and distributors were sent out the notification via email on 05/01/2024. The letter instructs the consignees to: 1. Quarantine and Discontinue Use of Affected Product: Identify, segregate, and discontinue use of the affected product in your inventory. 2. Complete and Return the attached Response Form: Complete the attached Response Form and return to Mermaid Medical by May 10, 2024 via email or by post. 3. Distributors/ If You Further Distributed Affected Product: Forward this communication to any customers that were distributed affected product. Instruct any of your customers to complete the response form and return to Mermaid Medical. Once they complete and return the response form, Mermaid Medical will provide instructions on how to return or destroy any affected product remaining in their inventory.
Recall details
- Recall number
- Z-2213-2024
- Status
- Open, Classified
- Initiated by the company
- May 1, 2024
- Posted by the FDA
- Jun 26, 2024
- Recalling firm
- Mermaid Medical A/S
- Quantity
- 190 devices
- Product code
- QEW
- FDA submissions
- K021641
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the country of Chile.
Product description
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.
Code information (models, lots, serial numbers)
Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- D*Clot® HD Rotational Thrombectomy System D*Clot® HD 6Fx65CMMermaid Medical A/S · Catheter, Embolectomy1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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