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ClariVein® IC

VASCULAR INSIGHTS, LLC · Model 85-018-E140S · UDI-DI 10854339004034

KRA Prescription

510(k) clearances

9,137

Adverse events (366 deaths)

137

Recalls

150

Facilities

Description

ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire connected to a proximally located integral battery motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features to facilitate physician-controlled infusion of the selected agent. The ClariVein® IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The ClariVein® IC has no user serviceable parts or capital equipment. It is fully disposable.

Recalls

Date	Firm	Reason
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.