Exact FDA event identifier

Event 94741

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: May 01, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Mermaid Medical A/S

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2213-2024

Recall number: Z-2213-2024
Initiated: May 01, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Mermaid Medical A/S
Quantity: 190 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

Code information

Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065

Distribution pattern

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.