ClariVein® IC 85-018-E140SRecalls & 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10854339004034), received between Jun 18, 2018 and Jul 20, 2022 — classified as 2 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (16 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
- Tear, Rip or Hole in Device Packaging16
- Unsealed Device Packaging3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Thrombosis2
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15069906 ↗MalfunctionJul 20, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15069885 ↗MalfunctionJul 20, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15069835 ↗MalfunctionJun 22, 2022Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14778494 ↗MalfunctionJun 22, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14778493 ↗MalfunctionJun 22, 2022Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14778489 ↗MalfunctionMay 19, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14439188 ↗MalfunctionApr 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14223128 ↗MalfunctionApr 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14223027 ↗MalfunctionFeb 1, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13417632 ↗MalfunctionFeb 1, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13417630 ↗MalfunctionFeb 1, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13417628 ↗MalfunctionJan 18, 2022Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13286307 ↗MalfunctionNov 2, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741232 ↗MalfunctionOct 12, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12615600 ↗MalfunctionOct 12, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12615599 ↗MalfunctionOct 5, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576889 ↗MalfunctionAug 11, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12306959 ↗MalfunctionJul 27, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12232918 ↗InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem
PHYSICIAN REPORTED A DEEP VEIN THROMBOSIS (DVT) POST PROCEDURE WHERE CLARIVEIN WAS USED TO DELIVER SCLEROSANTS.
Patient problems: Thrombosis
MAUDE report 7610940 ↗InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem
PHYSICIAN REPORTED A DEEP VEIN THROMBOSIS (DVT) POST PROCEDURE WHERE CLARIVEIN WAS USED TO DELIVER SCLEROSANTS.
Patient problems: Thrombosis
MAUDE report 7610782 ↗
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- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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