Recall record at a glance
| Official record | Z-2213-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Mermaid Medical A/S |
| Report date | Jul 3, 2024 |
| Recall initiation date | May 1, 2024 |
| Quantity | 190 devices |
| Location | Stenlose, Denmark |
Official 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.
Why the product was recalled
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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