The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The dispos
Summary
The FDA issued a Class II for The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based s by Mermaid Medical A/S. Reason: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact..
Details
Source
Device Recall
External ID
Z-2213-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
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.
Lot/Code Info: Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065
Quantity Affected: 190 devices
Reason for Recall
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-01
Company
Stenlose
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mermaid Medical A/S) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mermaid Medical A/S have FDA actions?
This is the only FDA action we have on record for Mermaid Medical A/S in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2213-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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