ClariVein® IC 65-018-E4SRecalls & reported problems

Vascular Insights, LLC · 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. " · Class 2

Quick summary

This ClariVein IC infusion catheter is a single-use device with a battery-powered rotating wire used to deliver fluid into veins. Most reports describe difficulty advancing the catheter into the sheath or a sheath tip that breaks, and in some cases the rotating tip became stuck on a vein valve during treatment. There are 32 adverse event reports, 5 involving injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 32
Deaths reported: 0
Injuries reported: 5
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10854339004027), received between Jun 8, 2017 and Apr 22, 2020 — classified as 5 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (26 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Fitting Problem26
Adverse Event Without Identified Device or Use Problem3
Break1
Device Handling Problem1
Insufficient Device Problem Information1

Patient problems

Vascular System (Circulation), Impaired26
Fever1
Foreign Body In Patient1
No Code Available1
No Known Impact Or Consequence To Patient1
Pulmonary Embolism1
Thrombus1
Unspecified Infection1

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT ON (B)(6) 2020 A MECHANICAL OCCLUSION CHEMICAL ABLATION [MOCA] PROCEDURE WAS SUCCESSFULLY COMPLETED ON A PATIENT. THE PATIENT WAS DISCHARGED TO HOME LATER THAT DAY. ON (B)(6) 2020 THE PRACTICE WAS NOTIFIED BY A FAMILY MEMBER THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH A PULMONARY EMBOLISM [PE].
Patient problems: Pulmonary Embolism
MAUDE report 9989050 ↗
InjuryMar 19, 2020Device Handling Problem; Device Handling Problem
THE ACCOUNT ALLEGES THAT DURING A MECHANOCHEMICAL ABLATION (MOCA) PROCEDURE, THE DISTAL ROTATING CATHETER BECAME STUCK WITH A VALVE OF A TARGETED VASCULATURE. THE PHYSICIAN HAD ACQUIRED ANTEGRADE VENOUS ACCESS THROUGH A VASCULAR SHEATH AND WAS ATTEMPTING TO DELIVER SCLEROSANT THROUGH THE ROTATING CATHETER WHEN THE CATHETER BECAME ENTANGLED WITHIN A VALVE OF THE PERIPHERY. ALL ATTEMPTS BY THE PHYSICIAN TO DISLODGE THE ROTATING CATHETER WERE UNSUCCESSFUL. A SURGICAL "CUTDOWN" PROCEDURE WAS NECESSARY TO SAFELY AND SUCCESSFULLY DISLODGE THE ROTATING CATHETER FORM THE PATIENT'S PERIPHERY WITH NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9857526 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7321157 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7321144 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7321090 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND OBSERVED THE DISPERSION WIRE UNSHEATHED OUT OF THE CATHETER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7321058 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND OBSERVED THE CATHETER SHEATH TIP TO BE DEFECTIVE. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320999 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320997 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320996 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER 65-018-E4S FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320995 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND OBSERVED THE CATHETER SHEATH WAS FRAYING AT THE DISTAL END. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320993 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER 65-018-E4S FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320992 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND OBSERVED THE CATHETER SHEATH TIP WAS LOOSE. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320989 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND OBSERVED THE CATHETER SHEATH TIP WAS LOOSE. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7320988 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7319974 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER 65-018-E4S FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7319972 ↗
MalfunctionMar 7, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7319918 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7318364 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7318359 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7318258 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND OBSERVED THE DISPERSION WIRE UNSHEATHED OUT OF THE CATHETER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7318081 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7317711 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER 65-018-E4S FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7317530 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER 65-018-E4S FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7317434 ↗
MalfunctionMar 6, 2018Fitting Problem; Fitting Problem
THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 7317429 ↗

Device details

UDI-DI	`10854339004027`
Brand	ClariVein® IC
Model	65-018-E4S
Company	Vascular Insights, LLC
Product code	KRA · Catheter, Continuous Flush
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jun 10, 2022

Device type (GMDN): Peripheral vascular intervention infusion catheter

A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.