Z-2213-2024Class II

The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French...

Name: Z-2213-2024 The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French...
Creator: Mermaid Medical A/S
Published: 2024-05-01
License: https://open.fda.gov/license/

Mermaid Medical A/S / initiated 2024-05-01 / Open, Classified / root cause: sterility

FDA source

Mermaid Medical A/S began a recall of 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... on 2024-05-01. FDA classified it as Class II and gives the reason as "Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2213-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-01
Posted: 2024-06-26
Recalling firm: Mermaid Medical A/S
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.
Product code: QEW Peripheral Mechanical Thrombectomy With Aspiration
Reason for recall: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 190 devices
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 codes and lots: Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2213-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2213-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-26

Product code QEW

K021641Class IIXtd Thrombectomy Catheter, Xx CmXtrak Medical, Inc. / cleared 2002-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)