Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 3, 2024
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
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mermaid Medical A/s recalled The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system ava… - a moderate-severity action.
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system ava… was recalled by Mermaid Medical A/s in July 3, 2024. Reason: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may n…. Check the official notice for the remedy. Verify recall #Z-2213-2024 with the FDA Devices before acting.
The recall
Mermaid Medical A/s issued this moderate-severity FDA Devices recall-Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may n….
- Moderate
- severity level
- 190 units
- affected scope
- Class II
- classification
- July 3, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2213-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2213-2024) was formally reported on July 3, 2024, with the manufacturer initiating the action on May 1, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Mermaid Medical A/s is listed as the recalling firm, operating out of Stenlose. Federal records list the affected scope as 190 devices.
The documented reason for this recall is: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
190 devices
Related Recalls
6
3 from same agency
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.
Reason for recall
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2213-2024 |
| Date reported | July 3, 2024 |
| Date initiated | May 1, 2024 |
| Recalling firm | Mermaid Medical A/s |
| Firm location | Stenlose |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2213-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mermaid Medical A/s. Units affected: 190 devices.
Why was this product recalled? ▼
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2024. Severity: Moderate. Recall number: Z-2213-2024.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2213-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 3, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.