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U.S. Department of Health and Human Services

Class 2 Device Recall DClot HD Rotational Thrombectomy System

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 Class 2 Device Recall DClot HD Rotational Thrombectomy Systemsee related information
Date Initiated by FirmMay 01, 2024
Date PostedJune 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2213-2024
Recall Event ID 94741
510(K)NumberK021641 
Product Classification Peripheral mechanical thrombectomy with aspiration - Product Code QEW
ProductThe 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 Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065
FEI Number 3007146453
Recalling Firm/
Manufacturer		 Mermaid Medical A/S
Frydensbergvej 25
Stenlose Denmark
For Additional Information ContactMatthew Genzman
914-867-2129
Manufacturer Reason
for Recall		Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce190 devices
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QEW
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