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ClariVein® IC

VASCULAR INSIGHTS, LLC · Model 45-018-E2S · UDI-DI 10854339004010

KRA Prescription

510(k) clearances

9,056

Adverse events (362 deaths)

Recalls

148

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
2023-12-18	Angiodynamics, Inc.	Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
2023-11-06	Merit Medical Systems, Inc.	The sterility of microcatheter and infusion system devices cannot be guaranteed.
2022-06-30	Micro Therapeutics, Inc.	Outer carton packaging of microcatheters were exposed to wet substance during transport.
2022-06-30	Micro Therapeutics, Inc.	Outer carton packaging of microcatheters were exposed to wet substance during transport.
2020-11-03	Boston Scientific Corporation	This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2017-11-09	Vascular Insights, LLC	Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction

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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.